Neonatal Umbilical Cord Treatment: A Prospective Study on Detachment Time and Complications With Different Topical Approaches | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Neonatal Umbilical Cord Treatment: A Prospective Study on Detachment Time and Complications With Different Topical Approaches Ilaria Farella, Domenico Martinelli, Boris Mola, Annalisa Resta, and 8 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7879810/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 5 You are reading this latest preprint version Abstract Background Umbilical granuloma (UG) is a common neonatal condition resulting from excessive granulation tissue at the umbilical stump, often leading to prolonged secretion and minor bleeding. While silver nitrate cauterization remains the standard treatment, there is growing interest in preventive approaches. This study compares different umbilical cord care regimens— Dry Care, Connettivina Silver Plus Spray®, Cliaxin Spray®, or Cicaben Powder®—focusing on umbilical detachment time and associated complications. Methods A prospective study was conducted from November 2020 to February 2022 at the Neonatology Department of the Regional General Hospital "F. Miulli," enrolling 1.699 neonates. Participants were assigned to one of four umbilical care regimens: Dry Care, Connettivina Silver Plus Spray, Cliaxin Spray, or Cicaben Powder. Treatment was administered in the hospital, and post-discharge follow-up on detachment time, bleeding, secretion, and UG formation were conducted on postnatal day 30. Statistical analyses included ANOVA and chi-square tests, with significance set at p < 0.05. Results The shortest detachment time was observed in the Cliaxin Spray group (6.5 ± 2.2 days, p < 0.05), while Dry Care had the longest (8.0 ± 2.8 days). UG incidence ranged from 4.7% to 7.8%, with no statistically significant differences between groups. Bleeding and umbilical discharge rates were significantly lower in the Cicaben Powder group (9.1% and 5.5%, respectively) compared to other regimens ( p < 0.05). No cases of omphalitis or sepsis occurred in any group. Conclusion This study compared Dry Care with dermatological formulations in a large prospective cohort. Cliaxin Spray was linked to faster cord detachment, while Cicaben Powder reduced bleeding and secretion. Although Dry Care remains common, it was associated with more minor complications. No regimen fully prevented all issues, but findings suggest current guidelines should be revisited, considering more individualized approaches. Further controlled studies are needed to confirm these results. Neonatal umbilical cord care umbilical granuloma umbilical cord complications Figures Figure 1 Figure 2 Figure 3 Introduction UG is a common benign anomaly in neonates, occurring in approximately 1 in 500 newborns ( 1 ). It is characterized by an overgrowth of granulation tissue at the base of the umbilical stump after separation, presenting as a soft, pink nodule, often secreting serous or seropurulent fluid. While generally self-limited, UG can predispose neonates to significant complications, including local infections such as omphalitis, which, if untreated, may progress to systemic conditions like necrotizing fasciitis ( 2 ). These complications carry serious consequences, with umbilical infections associated with a 46% higher mortality rate in neonates in developing regions compared to those without infections ( 3 ). The morbidity and mortality risks underscore the importance of addressing UG from a preventive standpoint. The pathogenesis of UG is closely linked to delayed or uneven separation of the umbilical stump, often driven by low-grade or subclinical infections. This disrupts the natural process of epithelialization, leading to persistent granulation tissue at the umbilical base. The excessive tissue can act as a focus for bacterial colonization, potentially escalating to sepsis or even life-threatening necrotizing fasciitis. Furthermore, spontaneous regression of untreated UG is not documented ( 4 ). These risks make UG more than a simple local condition, warranting proactive management to mitigate its impact on neonatal health. Current treatment protocols for UG predominantly involve silver nitrate cauterization, which is widely regarded as the first-line therapeutic option. While effective in reducing granulation tissue, silver nitrate cauterization is not without drawbacks. Improper application can lead to significant adverse events, including burns and ulcerations of the surrounding healthy tissue. Such complications not only prolong the healing process but may also introduce new entry points for infection, thereby compounding the initial condition. Moreover, the relatively high cost of silver nitrate cauterization can present a barrier to its use in resource-limited settings, further highlighting the need for preventive strategies ( 5 ). Materials and Methods This study aims to evaluate the effectiveness of four therapeutic approaches in preventing UG formation and to observe associated complications and the time required for cord detachment. Four therapeutic procedures were assessed over four-month periods each. Neonates admitted to the Neonatology Department received one of the following treatments twice daily during hospitalization. Upon discharge, mothers were allowed to choose between continuing the assigned therapy or reverting to others care approach until cord detachment. The therapeutic procedures were: 1) Dry care; 2) Connettivina Silver Plus Spray; 3) Cliaxin Spray; 4) Cicaben Powder. Procedure details 1. Dry Care This method involved keeping the umbilical stump clean and dry without the application of any substances. The stump was covered with a gauze dressing. In case of contamination with urine or feces, the area was cleaned with water and soap, dried, and a new gauze dressing was applied. 2. Connettivina Silver Plus Spray This method involved spraying the product twice daily on the umbilical area. International Nomenclature of Cosmetic Ingredient (INCI): Hyaluronic Acid Sodium Salt (0.20–0.25%), Metallic Silver (2.0%), Silicon Dioxide, Light Kaolin, Corn Starch, Vitamin E, Rice Oil, Terpinenol, Disiloxane, Propellant (N-butane). 3. Cliaxin Spray This method involved spraying the product twice daily on the umbilical area. INCI: Vitamin E, beta-glucan, α-bisabolol, tea tree oil, polidocanol, Centella asiatica, phthalimidoperoxycaproic acid, chlorhexidine, enriched with 10% zinc oxide. 4. Cicaben Powder This method involved applying an adequate amount of powder twice daily. INCI: Zinc oxide, magnesium oxide, corn starch, arnica montana extract, allantoin, undecylenic acid, arginine, glycine, proline, niacinamide. Study Design This prospective comparative study with sequential allocation was conducted in the Neonatology and Neonatal Intensive Care Unit of the Regional General Hospital "F. Miulli" in Acquaviva delle Fonti from November 1, 2020, to February 1, 2022. The neonates received four different treatments, administered in four sequential and temporally equivalent phases. From November 1, 2020, to February 22, 2021, dry cord care was provided. From February 23, 2021, to June 14, 2021, treatment with Connettivina Silver Plus Spray was applied. From June 15, 2021, to October 6, 2021, the neonates received Cliaxin Spray. Finally, from October 7, 2021, to February 1, 2022, Cicaben Powder was used. Upon discharge, mothers were instructed to continue the assigned therapy or transition to other care. Data Collection Data were collected and recorded in an Excel spreadsheet. At birth, information such as the newborn's name, birth date, weight, delivery type, premature rupture of membranes, amniotic fluid status, and gestational age was documented. Upon discharge, details regarding the treatment received in the hospital, informed consent for follow-up, and maternal contact information were recorded. A telephone interview was conducted on the 30° day after birth. The questions covered the timing of umbilical cord detachment, any umbilical complications (e.g., omphalitis, bleeding, purulent discharge, UG), and the method of at-home care. Additionally, data were collected on infants who returned to the hospital for the treatment of UG or complications related to cord detachment. Statistical Analysis Data were expressed as mean ± standard deviation or percentages. Comparisons were performed using ANOVA or independent sample t-tests. Categorical variables were analyzed using the chi-square test. A p-value < 0.05 was considered statistically significant. Inclusion and Exclusion Criteria Only full-term neonates who did not require neonatal intensive care were included in the study. The study protocol was reviewed and approved by the Ethics Committee of the Regional General Hospital "F. Miulli" (Study No. 6641; Executive Resolution No. 1563, dated November 7, 2016). Written informed consent was obtained from the parents or legal guardians of all neonates enrolled in the study. Results Between November 2020 and February 2022, a total of 2,593 neonates were born. Among these, 253 were excluded due to preterm birth and 154 because, although full-term, they required admission to the neonatal intensive care unit. This left 2,186 eligible full-term neonates. Of these, 487 were lost to follow-up, resulting in a final cohort of 1,699 newborns who completed the study. These infants were prospectively assigned at birth to one of four umbilical cord care groups. Table 1 presents their baseline characteristics. The distribution of male and female newborns was similar across all groups, with no statistically significant differences. Gestational age and birth weight were comparable among the groups, showing no significant variations. The mode of delivery was predominantly spontaneous, with a similar percentage in each treatment group. Likewise, the proportion of newborns experiencing premature rupture of membranes, lasting less than 18 hours and those born with clear amniotic fluid did not differ significantly among the groups. Regarding infant feeding practices, exclusive breastfeeding significantly differed among the groups, with a higher prevalence in the Cliaxin Spray group and a lower prevalence in the Cicaben Powder group. Table 1 Baseline characteristics of newborns undergoing the four umbilical cord treatments at birth. Parameters Dry (n = 449) Connettivina Silver Plus Spray® (n = 384) Cliaxin Spray® (n = 411) Cicaben Powder® (n = 455) P-value number 449 384 411 455 Male: Females ratio 235:214 191:193 198:213 222:233 NS Gestational age (weeks) 38.9 ± 1.6 39.1 ± 1.5 38.9 ± 1.6 39.0 ± 1.4 NS Birth weight (grams) 3240 ± 530 3309 ± 511 3231 ± 518 3255 ± 477 NS Spontaneous delivery (%) 65.6 64.5 68.1 65.2 NS PROM < 18 hours (%) 80.3 84.5 79.1 79.5 NS Clear amniotic fluid (%) 87.5 84.3 81.3 83.8 NS Exclusive breastfeeding (%) 59.0 59.6 60.8* 53.6* 0.03 Legend NS, not significant; PROM, premature rupture of membranes; p < 0.05 vs. Cicaben Powder® (*). Data are mean ± SD or %. ANOVA for continuous variables; chi-square test for categorical variables. We examined the transition between different methods used for umbilical cord care in the hospital and at home. In most cases, the initial hospital treatment was maintained at home, suggesting strong adherence to medical recommendations. However, a considerable number of cases shifted to alternative methods, indicating that some families opted for treatments not explicitly listed. While the majority of transitions between specific named treatments were minimal, a small number of cases switched from Dry to other methods, such as Cliaxin Spray and Cicaben Powder , suggesting that some parents may have sought additional care at home. Specifically, those initially treated with Dry , Connettivina Silver Plus Spray , and Cliaxin Spray were more likely to change the medication compared to patients in the Cicaben Powder group (Table 2 ). Table 2 Percentage of patients who changed umbilical cord care at home for each group. Dry Connettivina Silver Plus Spray Cliaxin Spray Cicaben Powder P Total (number) 449 384 411 455 % of shift 125(27.8) * 115 (29.9)* 111(27)* 93(20.4) 0.010 Legend p < 0.05 vs. Cicaben Powder® (*). Data are %. Chi-square test for categorical variables. For the purposes of statistical comparison, we included only those neonates whose families continued at home the same umbilical cord care regimen that had been initiated during hospitalization. Subjects who changed or interrupted the treatment post-discharge were excluded from the final comparative analysis, as their data were not considered statistically comparable due to variability in exposure. Patients treated with Cliaxin Spray exhibited the shortest umbilical stump detachment time (6.5 ± 2.2 days, P < 0.05) with Dry care showing the longest detachment time (8.0 ± 2.8 days, P < 0.05 vs. Cliaxin Spray) (Table 3 ) Table 3 Outcomes by treatment group: detachment time and complication rates in neonatal cord care. Dry Connettivina Silver Plus Spray Cliaxin Spray Cicaben Powder P n = 324 n = 269 n = 300 n = 362 Umbilical stump detachment (days) 8.0 ± 2.8*§ 7.3 ± 2.5 § 6.5 ± 2.2* 7.0 ± 1.9 <0.001 Granuloma 7,4% 7,8% 5,7% 4,7% NS Bleeding 22,5%* 26,0%* 22,0%* 9,1% < 0.001 Discharge 10,5%* 10,0%* 13,0%* 5,5% 0.01 Bleeding or Discharge 33,0%* 36,1%* 35,0%* 14,6% < 0.001 Legend p < 0.05 vs. Cicaben Powder® (*); p < 0.05 vs. Cliaxin Spray® (§). NS, not significant. Data are mean ± SD or %. ANOVA for continuous variables; chi-square test for categorical variables. The overall incidence of UG formation was higher in the Connettivina Silver Plus Spray group compared to the Cicaben Powder group although the difference was not statistically significant (P = 0.322) (Fig. 1 ). Bleeding incidence was notably lower in the Cicaben Powder group compared to other groups (Fig. 2 ). Similarly, umbilical discharge rates were the lower with Cicaben Powder compared to other groups (Fig. 3 ). When considering either bleeding or secretion, Cicaben Powder had the lower rate (14.6%) compared to other groups (P < 0.001). None of the patients developed omphalitis or sepsis related to umbilical infection. Discussion This study is the first to compare Dry Care, Connettivina Silver Plus Spray®, Cliaxin Spray®, and Cicaben Powder® in the context of umbilical cord care, focusing specifically on non-antiseptic, dermatologically active treatments with reparative, protective, and anti-inflammatory properties. While previous studies have primarily addressed cord separation time and infection prevention using antiseptics, antibiotics, or alternative substances such as salicylic sugar or micronized green clay powders clay powder ( 7 ); ( 8 ) ( 9 )— our investigation uniquely evaluates topical products that combine mild antimicrobial action with tissue repair, hydration, and regenerative support. This approach extends beyond infection control, actively supporting skin integrity and optimizing postnatal healing, offering new perspectives on umbilical cord care in neonatal medicine. The World Health Organization recommends dry cord care as the standard approach for newborns in low-risk settings, as outlined in its 2014 guidelines on newborn health ( Recommendations on Newborn Health: Umbilical Cord Care , Geneva: WHO, 2014). Even in high-income countries with very low neonatal mortality rates, proper umbilical cord care during the first month of life remains crucial. While common adverse events include irritation, redness, navel discharge, and minor bleeding, severe complications such as omphalitis, sepsis, and umbilical UG are rare ( 10 ). In our study, Cicaben Powder was associated with the lowest rates of bleeding and secretion, while Cliaxin Spray resulted in the shortest umbilical cord detachment time. UG incidence did not significantly differ among groups. Other studies have examined the effects of different umbilical care methods on secretion and bleeding in the first days of life. Quattrin et al. found that neither dry care nor the application of 70% alcohol affected hemorrhage risk ( 11 ), a result further confirmed by a meta-analysis by Al-Shehri et al. ( 12 ). Similarly, Kapellen et al. reported that dry cord care was associated with a higher incidence of cord-related adverse events, including irritation, lesions, and secretion, compared to chlorhexidine powder ( 13 ). The average umbilical cord detachment time varies widely in the literature, ranging from 4 to 16 days depending on the care method and study context. Studies where no substances were applied to the cord reported a mean detachment time of approximately 9 days ( 8 , 14 ). Similarly, research comparing different umbilical cord care regimens has shown that dry care generally leads to longer detachment times ( 15 ). Our findings align with previous studies, particularly those comparing chlorhexidine powder with dry care, where prolonged detachment times were observed in the absence of active treatment ( 9 ). In our study, patients treated with Cicaben Powder had a shorter mean umbilical cord detachment time compared to the Dry Care group but a longer detachment time than those in the Cliaxin Spray group. It is important to note that patients were recruited during different times of the year, and the spring season appears to influence cord detachment time ( 16 ). Although delayed umbilical cord separation has no clear clinical significance, it has social and logistical implications. A prolonged detachment period may cause anxiety among mothers and lead to increased demand for home visits by midwives. Consequently, both healthcare providers and families often prefer a shorter separation time to minimize concerns and optimize postnatal care ( 17 ). UG incidence in our study ranged from 4.7% to 7.8%, consistent with previous literature reporting no significant differences between dry care and other methods such as chlorhexidine powder ( 13 ). Similarly, Al-Shehri et al. found that neither dry care nor the application of 70% alcohol affected UG incidence ( 12 ). Our data suggest that UG formation is associated with delayed cord detachment, and both bleeding and secretion appear to increase the likelihood of UG development, although specific percentages are not shown. This association highlights the importance of selecting appropriate umbilical care methods to minimize complications. Although breastfeeding rates varied across groups, no correlation with umbilical outcomes was observed. While previous studies have reported a significant association between breastfeeding and reduced umbilical cord infections ( 18 ) our findings suggest that while breastfeeding may lower infection risks in certain settings, other factors—such as the type of umbilical care applied—play a decisive role in neonatal umbilical health outcomes. This study has some limitations, particularly the lack of blinding, which could introduce bias. However, to minimize treatment bias, a structured protocol was implemented, assigning a specific umbilical cord care regimen to all newborns delivered within designated timeframes. Each treatment was applied for a set period of consecutive months, ensuring that all infants born during that timeframe received the same care method. This approach helped maintain consistency among participants and reduced variability in treatment exposure. Additionally, while we accounted for seasonal variations, other external factors—such as hospital policies, environmental conditions, and genetic predispositions—could have influenced the results. Future research should include randomized controlled trials with blinded assessments to further validate our findings. Conclusion This study offers new insights into neonatal umbilical cord care by comparing conventional dry care with dermatological formulations in a large prospective cohort. While Dry Care remains widely recommended, its association with longer detachment times and higher rates of bleeding and secretion invites reflection on whether it should continue to be considered the standard approach in all settings. The findings suggest that dermatological formulations may offer advantages in specific aspects of umbilical healing, such as managing secretion or bleeding, without significantly affecting the incidence of umbilical granuloma. However, no regimen proved fully effective in preventing all complications. Overall, these results support the need to revisit current umbilical care guidelines, considering whether individualized or alternative approaches could optimize outcomes. Further research is warranted to validate these findings and inform evidence-based recommendations for routine neonatal cord care. Declarations Ethics approval and consent to participate The study protocol was approved by the Ethics Committee of the Regional General Hospital “F. Miulli” (Study No. 6641; Executive Resolution No. 1563, 7 November 2016). Written informed consent to participate was obtained from the parents or legal guardians of all neonates enrolled. Consent for Publication All authors have read and approved the final version of the manuscript and consent to its publication. Informed consent for the publication of anonymized data was obtained from the parents or legal guardians of the neonates involved in the study. Availability of Data and Materials The datasets used and analyzed during the current study are available from the corresponding author upon reasonable request. Any data shared will comply with applicable ethical guidelines and privacy regulations. Competing Interests The authors declare no competing interests related to this study. The study was conducted independently, without any influence from commercial entities related to the products evaluated. Funding This research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors. Authors' Contributions Ilaria Farella was responsible for conceptualization, study design, supervision, data interpretation, manuscript drafting, and project administration. Pietro Guida carried out data curation and formal statistical analysis, verified the underlying data, and reviewed the manuscript. Giuseppe Latorre contributed to methodology and validation and critically revised the manuscript for important intellectual content. Venturina Caporusso and Palma Reginella oversaw patient care, data acquisition, follow-up coordination, and procedural oversight. Domenico Martinelli, Boris Mola, Annalisa Resta, Benedetta Giannico, Ornella Amato, Fabrizia De Palma, and Sabrina Lozupone contributed to data collection, clinical management, and manuscript revision. All authors read and approved the final version of the manuscript and agree to be accountable for all aspects of the work. Acknowledgements We thank the medical and nursing staff of the Neonatology and Neonatal Intensive Care Unit, Regional General Hospital “F. Miulli,” for their invaluable contributions to patient care and data collection. We are also grateful to the families who participated in this study for their collaboration and trust. Competing interests The authors declare no competing interests. Authors' Information For correspondence and inquiries, please contact: Ilaria Farella Neonatology and Neonatal Intensive Care Unit, Regional General Hospital "F. Miulli," Acquaviva delle Fonti, Italy. Email: [email protected] References Nagar H. Umbilical granuloma: a new approach to an old problem. Pediatr Surg Int. 2001;17(7):513–4. Hegazy AA. Anatomy and embryology of umbilicus in newborns: a review and clinical correlations. Front Med. 2016;10(3):271–7. Mullany LC, Darmstadt GL, Katz J, Khatry SK, Leclerq SC, Adhikari RK, et al. Risk of mortality subsequent to umbilical cord infection among newborns of southern Nepal: cord infection and mortality. Pediatr Infect Dis J. 2009;28(1):17–20. Banerjee A, Jain RA, Munghate GS, Bodhanwala M, Bendre PS. Common Salt versus Silver Nitrate for the Treatment of Umbilical Granuloma in Infants: An Open-label, Single-center, Pilot Randomized Controlled Trial. J Indian Association Pediatr Surg. 2024;29(3):199–203. 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The Pediatric infectious disease journal. 2009;28(6):503–9. Cite Share Download PDF Status: Under Review Version 1 posted Editorial decision: Major revision 24 Mar, 2026 Reviewers agreed at journal 01 Feb, 2026 Reviewers invited by journal 12 Jan, 2026 Editor assigned by journal 23 Oct, 2025 First submitted to journal 22 Oct, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. 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13:03:03","extension":"xml","order_by":13,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":70573,"visible":true,"origin":"","legend":"","description":"","filename":"ITJPD25011890structuring.xml","url":"https://assets-eu.researchsquare.com/files/rs-7879810/v1/17efcb22173db0be46bf5c79.xml"},{"id":100407246,"identity":"de424c09-64c7-4a5d-93ca-81a70e7e24ac","added_by":"auto","created_at":"2026-01-16 13:04:12","extension":"html","order_by":14,"title":"","display":"","copyAsset":false,"role":"acdc-reference","size":81612,"visible":true,"origin":"","legend":"","description":"","filename":"earlyproof.html","url":"https://assets-eu.researchsquare.com/files/rs-7879810/v1/d7c11f417ba0698e8674f0ed.html"},{"id":100407156,"identity":"585f9b2e-25ab-4b6b-912b-c469f5b13154","added_by":"auto","created_at":"2026-01-16 13:03:56","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":42457,"visible":true,"origin":"","legend":"\u003cp\u003eIncidence of umbilical granuloma by treatment group.\u003c/p\u003e","description":"","filename":"floatimage1.png","url":"https://assets-eu.researchsquare.com/files/rs-7879810/v1/8c8ecc6cd43e118618ed6e57.png"},{"id":100407250,"identity":"66ae29d7-c5f6-4d00-a111-bb16855411a5","added_by":"auto","created_at":"2026-01-16 13:04:12","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":44799,"visible":true,"origin":"","legend":"\u003cp\u003eIncidence of bleeding by treatment group.\u003c/p\u003e","description":"","filename":"floatimage2.png","url":"https://assets-eu.researchsquare.com/files/rs-7879810/v1/1adb00b5ebac09e29173e50e.png"},{"id":100406844,"identity":"a7357bb0-1f9e-4773-97a1-30cb70793b1e","added_by":"auto","created_at":"2026-01-16 13:03:28","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":290182,"visible":true,"origin":"","legend":"\u003cp\u003eIncidence of umbilical discharge by treatment group.\u003c/p\u003e","description":"","filename":"floatimage3.png","url":"https://assets-eu.researchsquare.com/files/rs-7879810/v1/869503b6d8e90bed75a893b9.png"},{"id":100594556,"identity":"21dd638b-cb6c-4376-b6f7-85009b9bdb27","added_by":"auto","created_at":"2026-01-19 13:42:40","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1083464,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7879810/v1/2deac0a0-dca8-48be-b573-f7063c0166c4.pdf"}],"financialInterests":"","formattedTitle":"\u003cp\u003eNeonatal Umbilical Cord Treatment: A Prospective Study on Detachment Time and Complications With Different Topical Approaches\u003c/p\u003e","fulltext":[{"header":"Introduction","content":"\u003cp\u003eUG is a common benign anomaly in neonates, occurring in approximately 1 in 500 newborns (\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e). It is characterized by an overgrowth of granulation tissue at the base of the umbilical stump after separation, presenting as a soft, pink nodule, often secreting serous or seropurulent fluid. While generally self-limited, UG can predispose neonates to significant complications, including local infections such as omphalitis, which, if untreated, may progress to systemic conditions like necrotizing fasciitis (\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e). These complications carry serious consequences, with umbilical infections associated with a 46% higher mortality rate in neonates in developing regions compared to those without infections (\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e). The morbidity and mortality risks underscore the importance of addressing UG from a preventive standpoint.\u003c/p\u003e \u003cp\u003eThe pathogenesis of UG is closely linked to delayed or uneven separation of the umbilical stump, often driven by low-grade or subclinical infections. This disrupts the natural process of epithelialization, leading to persistent granulation tissue at the umbilical base. The excessive tissue can act as a focus for bacterial colonization, potentially escalating to sepsis or even life-threatening necrotizing fasciitis. Furthermore, spontaneous regression of untreated UG is not documented (\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e). These risks make UG more than a simple local condition, warranting proactive management to mitigate its impact on neonatal health.\u003c/p\u003e \u003cp\u003eCurrent treatment protocols for UG predominantly involve silver nitrate cauterization, which is widely regarded as the first-line therapeutic option. While effective in reducing granulation tissue, silver nitrate cauterization is not without drawbacks. Improper application can lead to significant adverse events, including burns and ulcerations of the surrounding healthy tissue. Such complications not only prolong the healing process but may also introduce new entry points for infection, thereby compounding the initial condition. Moreover, the relatively high cost of silver nitrate cauterization can present a barrier to its use in resource-limited settings, further highlighting the need for preventive strategies (\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e).\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cp\u003eThis study aims to evaluate the effectiveness of four therapeutic approaches in preventing UG formation and to observe associated complications and the time required for cord detachment. Four therapeutic procedures were assessed over four-month periods each. Neonates admitted to the Neonatology Department received one of the following treatments twice daily during hospitalization. Upon discharge, mothers were allowed to choose between continuing the assigned therapy or reverting to others care approach until cord detachment.\u003c/p\u003e \u003cp\u003eThe therapeutic procedures were: 1) Dry care; 2) Connettivina Silver Plus Spray; 3) Cliaxin Spray; 4) Cicaben Powder.\u003c/p\u003e \u003cp\u003e \u003cem\u003eProcedure details\u003c/em\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003e1. Dry Care\u003c/p\u003e \u003cp\u003eThis method involved keeping the umbilical stump clean and dry without the application of any substances. The stump was covered with a gauze dressing. In case of contamination with urine or feces, the area was cleaned with water and soap, dried, and a new gauze dressing was applied.\u003c/p\u003e \u003cp\u003e2. Connettivina Silver Plus Spray\u003c/p\u003e \u003cp\u003eThis method involved spraying the product twice daily on the umbilical area.\u003c/p\u003e \u003cp\u003eInternational Nomenclature of Cosmetic Ingredient (INCI): Hyaluronic Acid Sodium Salt (0.20\u0026ndash;0.25%), Metallic Silver (2.0%), Silicon Dioxide, Light Kaolin, Corn Starch, Vitamin E, Rice Oil, Terpinenol, Disiloxane, Propellant (N-butane).\u003c/p\u003e \u003cp\u003e3. Cliaxin Spray\u003c/p\u003e \u003cp\u003eThis method involved spraying the product twice daily on the umbilical area.\u003c/p\u003e \u003cp\u003eINCI: Vitamin E, beta-glucan, α-bisabolol, tea tree oil, polidocanol, Centella asiatica, phthalimidoperoxycaproic acid, chlorhexidine, enriched with 10% zinc oxide.\u003c/p\u003e \u003cp\u003e4. Cicaben Powder\u003c/p\u003e \u003cp\u003eThis method involved applying an adequate amount of powder twice daily.\u003c/p\u003e \u003cp\u003eINCI: Zinc oxide, magnesium oxide, corn starch, arnica montana extract, allantoin, undecylenic acid, arginine, glycine, proline, niacinamide.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design\u003c/h2\u003e \u003cp\u003e This prospective comparative study with sequential allocation was conducted in the Neonatology and Neonatal Intensive Care Unit of the Regional General Hospital \"F. Miulli\" in Acquaviva delle Fonti from November 1, 2020, to February 1, 2022. The neonates received four different treatments, administered in four sequential and temporally equivalent phases. From November 1, 2020, to February 22, 2021, dry cord care was provided. From February 23, 2021, to June 14, 2021, treatment with Connettivina Silver Plus Spray was applied. From June 15, 2021, to October 6, 2021, the neonates received Cliaxin Spray. Finally, from October 7, 2021, to February 1, 2022, Cicaben Powder was used.\u003c/p\u003e \u003cp\u003eUpon discharge, mothers were instructed to continue the assigned therapy or transition to other care.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eData Collection\u003c/h3\u003e\n\u003cp\u003eData were collected and recorded in an Excel spreadsheet. At birth, information such as the newborn's name, birth date, weight, delivery type, premature rupture of membranes, amniotic fluid status, and gestational age was documented. Upon discharge, details regarding the treatment received in the hospital, informed consent for follow-up, and maternal contact information were recorded.\u003c/p\u003e \u003cp\u003eA telephone interview was conducted on the 30\u0026deg; day after birth. The questions covered the timing of umbilical cord detachment, any umbilical complications (e.g., omphalitis, bleeding, purulent discharge, UG), and the method of at-home care.\u003c/p\u003e \u003cp\u003eAdditionally, data were collected on infants who returned to the hospital for the treatment of UG or complications related to cord detachment.\u003c/p\u003e \u003cdiv id=\"Sec5\" class=\"Section2\"\u003e \u003ch2\u003eStatistical Analysis\u003c/h2\u003e \u003cp\u003eData were expressed as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation or percentages. Comparisons were performed using ANOVA or independent sample t-tests. Categorical variables were analyzed using the chi-square test. A p-value\u0026thinsp;\u0026lt;\u0026thinsp;0.05 was considered statistically significant.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eInclusion and Exclusion Criteria\u003c/h3\u003e\n\u003cp\u003eOnly full-term neonates who did not require neonatal intensive care were included in the study. The study protocol was reviewed and approved by the Ethics Committee of the Regional General Hospital \"F. Miulli\" (Study No. 6641; Executive Resolution No. 1563, dated November 7, 2016). Written informed consent was obtained from the parents or legal guardians of all neonates enrolled in the study.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eBetween November 2020 and February 2022, a total of 2,593 neonates were born. Among these, 253 were excluded due to preterm birth and 154 because, although full-term, they required admission to the neonatal intensive care unit. This left 2,186 eligible full-term neonates. Of these, 487 were lost to follow-up, resulting in a final cohort of 1,699 newborns who completed the study. These infants were prospectively assigned at birth to one of four umbilical cord care groups. Table\u0026nbsp;\u003cspan refid=\"Tab1\" class=\"InternalRef\"\u003e1\u003c/span\u003e presents their baseline characteristics. The distribution of male and female newborns was similar across all groups, with no statistically significant differences. Gestational age and birth weight were comparable among the groups, showing no significant variations.\u003c/p\u003e \u003cp\u003eThe mode of delivery was predominantly spontaneous, with a similar percentage in each treatment group. Likewise, the proportion of newborns experiencing premature rupture of membranes, lasting less than 18 hours and those born with clear amniotic fluid did not differ significantly among the groups.\u003c/p\u003e \u003cp\u003eRegarding infant feeding practices, exclusive breastfeeding significantly differed among the groups, with a higher prevalence in the Cliaxin Spray group and a lower prevalence in the Cicaben Powder group.\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eBaseline characteristics of newborns undergoing the four umbilical cord treatments at birth.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e \u003cp\u003eParameters\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDry\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;449)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eConnettivina Silver Plus\u003c/p\u003e \u003cp\u003eSpray\u0026reg;\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;384)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eCliaxin Spray\u0026reg;\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;411)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCicaben Powder\u0026reg;\u003c/p\u003e \u003cp\u003e(n\u0026thinsp;=\u0026thinsp;455)\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eP-value\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003enumber\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e449\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e384\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e411\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e455\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eMale: Females ratio\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e235:214\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e191:193\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e198:213\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e222:233\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGestational age (weeks)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e38.9\u0026thinsp;\u0026plusmn;\u0026thinsp;1.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e39.1\u0026thinsp;\u0026plusmn;\u0026thinsp;1.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e38.9\u0026thinsp;\u0026plusmn;\u0026thinsp;1.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e39.0\u0026thinsp;\u0026plusmn;\u0026thinsp;1.4\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBirth weight (grams)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e3240\u0026thinsp;\u0026plusmn;\u0026thinsp;530\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e3309\u0026thinsp;\u0026plusmn;\u0026thinsp;511\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e3231\u0026thinsp;\u0026plusmn;\u0026thinsp;518\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e3255\u0026thinsp;\u0026plusmn;\u0026thinsp;477\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eSpontaneous delivery (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e65.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e64.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e68.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e65.2\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003ePROM\u0026thinsp;\u0026lt;\u0026thinsp;18 hours (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e80.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e84.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e79.1\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e79.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eClear amniotic fluid (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e87.5\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e84.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e81.3\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e83.8\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eExclusive breastfeeding (%)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e59.0\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e59.6\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e60.8*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e53.6*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.03\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eLegend\u003c/strong\u003e \u003cp\u003eNS, not significant; PROM, premature rupture of membranes; \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 vs. Cicaben Powder\u0026reg; (*). Data are mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD or %. ANOVA for continuous variables; chi-square test for categorical variables.\u003c/p\u003e \u003c/p\u003e \u003cp\u003eWe examined the transition between different methods used for umbilical cord care in the hospital and at home. In most cases, the initial hospital treatment was maintained at home, suggesting strong adherence to medical recommendations. However, a considerable number of cases shifted to alternative methods, indicating that some families opted for treatments not explicitly listed. While the majority of transitions between specific named treatments were minimal, a small number of cases switched from \u003cem\u003eDry\u003c/em\u003e to other methods, such as \u003cem\u003eCliaxin Spray\u003c/em\u003e and \u003cem\u003eCicaben Powder\u003c/em\u003e, suggesting that some parents may have sought additional care at home.\u003c/p\u003e \u003cp\u003eSpecifically, those initially treated with \u003cem\u003eDry\u003c/em\u003e, \u003cem\u003eConnettivina Silver Plus Spray\u003c/em\u003e, and \u003cem\u003eCliaxin Spray\u003c/em\u003e were more likely to change the medication compared to patients in the \u003cem\u003eCicaben Powder\u003c/em\u003e group (Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab2\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 2\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003ePercentage of patients who changed umbilical cord care at home for each group.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"char\" char=\".\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDry\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eConnettivina Silver Plus Spray\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eCliaxin Spray\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCicaben Powder\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eP\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eTotal (number)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e449\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e384\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e411\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e455\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003e% of shift\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e125(27.8)\u003csup\u003e*\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e115 (29.9)*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e111(27)*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e93(20.4)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"char\" char=\".\" colname=\"c6\"\u003e \u003cp\u003e0.010\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eLegend\u003c/strong\u003e \u003cp\u003e \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 vs. Cicaben Powder\u0026reg; (*). Data are %. Chi-square test for categorical variables.\u003c/p\u003e \u003c/p\u003e \u003cp\u003eFor the purposes of statistical comparison, we included only those neonates whose families continued at home the same umbilical cord care regimen that had been initiated during hospitalization. Subjects who changed or interrupted the treatment post-discharge were excluded from the final comparative analysis, as their data were not considered statistically comparable due to variability in exposure.\u003c/p\u003e \u003cp\u003ePatients treated with Cliaxin Spray exhibited the shortest umbilical stump detachment time (6.5\u0026thinsp;\u0026plusmn;\u0026thinsp;2.2 days, P\u0026thinsp;\u0026lt;\u0026thinsp;0.05) with Dry care showing the longest detachment time (8.0\u0026thinsp;\u0026plusmn;\u0026thinsp;2.8 days, P\u0026thinsp;\u0026lt;\u0026thinsp;0.05 vs. Cliaxin Spray) (Table\u0026nbsp;\u003cspan refid=\"Tab3\" class=\"InternalRef\"\u003e3\u003c/span\u003e)\u003c/p\u003e \u003cp\u003e \u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab3\" border=\"1\"\u003e \u003ccaption language=\"En\"\u003e \u003cdiv class=\"CaptionNumber\"\u003eTable 3\u003c/div\u003e \u003cdiv class=\"CaptionContent\"\u003e \u003cp\u003eOutcomes by treatment group: detachment time and complication rates in neonatal cord care.\u003c/p\u003e \u003c/div\u003e \u003c/caption\u003e \u003ccolgroup cols=\"6\"\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c4\" colnum=\"4\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c5\" colnum=\"5\"\u003e\u003c/div\u003e \u003cdiv align=\"left\" class=\"colspec\" colname=\"c6\" colnum=\"6\"\u003e\u003c/div\u003e \u003cthead\u003e \u003ctr\u003e \u003cth align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/th\u003e \u003cth align=\"left\" colname=\"c2\"\u003e \u003cp\u003eDry\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c3\"\u003e \u003cp\u003eConnettivina Silver Plus Spray\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c4\"\u003e \u003cp\u003eCliaxin Spray\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c5\"\u003e \u003cp\u003eCicaben Powder\u003c/p\u003e \u003c/th\u003e \u003cth align=\"left\" colname=\"c6\"\u003e \u003cp\u003eP\u003c/p\u003e \u003c/th\u003e \u003c/tr\u003e \u003c/thead\u003e \u003ctbody\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e\u0026nbsp;\u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;324\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;269\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;300\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003en\u0026thinsp;=\u0026thinsp;362\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e\u0026nbsp;\u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eUmbilical stump detachment (days)\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e8.0\u0026thinsp;\u0026plusmn;\u0026thinsp;2.8*\u0026sect;\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7.3\u0026thinsp;\u0026plusmn;\u0026thinsp;2.5\u003csup\u003e\u0026sect;\u003c/sup\u003e\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e6.5\u0026thinsp;\u0026plusmn;\u0026thinsp;2.2*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e7.0\u0026thinsp;\u0026plusmn;\u0026thinsp;1.9\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eGranuloma\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e7,4%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e7,8%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e5,7%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e4,7%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003eNS\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBleeding\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e22,5%*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e26,0%*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e22,0%*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e9,1%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eDischarge\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e10,5%*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e10,0%*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e13,0%*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e5,5%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e0.01\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003ctr\u003e \u003ctd align=\"left\" colname=\"c1\"\u003e \u003cp\u003eBleeding or Discharge\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c2\"\u003e \u003cp\u003e33,0%*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c3\"\u003e \u003cp\u003e36,1%*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c4\"\u003e \u003cp\u003e35,0%*\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c5\"\u003e \u003cp\u003e14,6%\u003c/p\u003e \u003c/td\u003e \u003ctd align=\"left\" colname=\"c6\"\u003e \u003cp\u003e\u0026lt;\u0026thinsp;0.001\u003c/p\u003e \u003c/td\u003e \u003c/tr\u003e \u003c/tbody\u003e \u003c/colgroup\u003e \u003c/table\u003e\u003c/div\u003e \u003c/p\u003e \u003cp\u003e \u003cstrong\u003eLegend\u003c/strong\u003e \u003cp\u003e \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 vs. Cicaben Powder\u0026reg; (*); \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 vs. Cliaxin Spray\u0026reg; (\u0026sect;). NS, not significant. Data are mean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD or %. ANOVA for continuous variables; chi-square test for categorical variables.\u003c/p\u003e \u003c/p\u003e \u003cp\u003eThe overall incidence of UG formation was higher in the Connettivina Silver Plus Spray group compared to the Cicaben Powder group although the difference was not statistically significant (P\u0026thinsp;=\u0026thinsp;0.322) (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eBleeding incidence was notably lower in the Cicaben Powder group compared to other groups (Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eSimilarly, umbilical discharge rates were the lower with Cicaben Powder compared to other groups (Fig.\u0026nbsp;\u003cspan refid=\"Fig3\" class=\"InternalRef\"\u003e3\u003c/span\u003e).\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eWhen considering either bleeding or secretion, Cicaben Powder had the lower rate (14.6%) compared to other groups (P\u0026thinsp;\u0026lt;\u0026thinsp;0.001).\u003c/p\u003e \u003cp\u003eNone of the patients developed omphalitis or sepsis related to umbilical infection.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis study is the first to compare Dry Care, Connettivina Silver Plus Spray\u0026reg;, Cliaxin Spray\u0026reg;, and Cicaben Powder\u0026reg; in the context of umbilical cord care, focusing specifically on non-antiseptic, dermatologically active treatments with reparative, protective, and anti-inflammatory properties.\u003c/p\u003e \u003cp\u003eWhile previous studies have primarily addressed cord separation time and infection prevention using antiseptics, antibiotics, or alternative substances such as salicylic sugar or micronized green clay powders clay powder (\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e); (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e) (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e)\u0026mdash; our investigation uniquely evaluates topical products that combine mild antimicrobial action with tissue repair, hydration, and regenerative support.\u003c/p\u003e \u003cp\u003eThis approach extends beyond infection control, actively supporting skin integrity and optimizing postnatal healing, offering new perspectives on umbilical cord care in neonatal medicine.\u003c/p\u003e \u003cp\u003eThe World Health Organization recommends dry cord care as the standard approach for newborns in low-risk settings, as outlined in its 2014 guidelines on newborn health (\u003cem\u003eRecommendations on Newborn Health: Umbilical Cord Care\u003c/em\u003e, Geneva: WHO, 2014). Even in high-income countries with very low neonatal mortality rates, proper umbilical cord care during the first month of life remains crucial. While common adverse events include irritation, redness, navel discharge, and minor bleeding, severe complications such as omphalitis, sepsis, and umbilical UG are rare (\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIn our study, Cicaben Powder was associated with the lowest rates of bleeding and secretion, while Cliaxin Spray resulted in the shortest umbilical cord detachment time. UG incidence did not significantly differ among groups.\u003c/p\u003e \u003cp\u003eOther studies have examined the effects of different umbilical care methods on secretion and bleeding in the first days of life. Quattrin et al. found that neither dry care nor the application of 70% alcohol affected hemorrhage risk (\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e), a result further confirmed by a meta-analysis by Al-Shehri et al. (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Similarly, Kapellen et al. reported that dry cord care was associated with a higher incidence of cord-related adverse events, including irritation, lesions, and secretion, compared to chlorhexidine powder (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe average umbilical cord detachment time varies widely in the literature, ranging from 4 to 16 days depending on the care method and study context. Studies where no substances were applied to the cord reported a mean detachment time of approximately 9 days (\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e, \u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e). Similarly, research comparing different umbilical cord care regimens has shown that dry care generally leads to longer detachment times (\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e). Our findings align with previous studies, particularly those comparing chlorhexidine powder with dry care, where prolonged detachment times were observed in the absence of active treatment (\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eIn our study, patients treated with Cicaben Powder had a shorter mean umbilical cord detachment time compared to the Dry Care group but a longer detachment time than those in the Cliaxin Spray group. It is important to note that patients were recruited during different times of the year, and the spring season appears to influence cord detachment time (\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eAlthough delayed umbilical cord separation has no clear clinical significance, it has social and logistical implications. A prolonged detachment period may cause anxiety among mothers and lead to increased demand for home visits by midwives. Consequently, both healthcare providers and families often prefer a shorter separation time to minimize concerns and optimize postnatal care (\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eUG incidence in our study ranged from 4.7% to 7.8%, consistent with previous literature reporting no significant differences between dry care and other methods such as chlorhexidine powder (\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e). Similarly, Al-Shehri et al. found that neither dry care nor the application of 70% alcohol affected UG incidence (\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e). Our data suggest that UG formation is associated with delayed cord detachment, and both bleeding and secretion appear to increase the likelihood of UG development, although specific percentages are not shown. This association highlights the importance of selecting appropriate umbilical care methods to minimize complications.\u003c/p\u003e \u003cp\u003eAlthough breastfeeding rates varied across groups, no correlation with umbilical outcomes was observed. While previous studies have reported a significant association between breastfeeding and reduced umbilical cord infections (\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e) our findings suggest that while breastfeeding may lower infection risks in certain settings, other factors\u0026mdash;such as the type of umbilical care applied\u0026mdash;play a decisive role in neonatal umbilical health outcomes.\u003c/p\u003e \u003cp\u003eThis study has some limitations, particularly the lack of blinding, which could introduce bias. However, to minimize treatment bias, a structured protocol was implemented, assigning a specific umbilical cord care regimen to all newborns delivered within designated timeframes. Each treatment was applied for a set period of consecutive months, ensuring that all infants born during that timeframe received the same care method. This approach helped maintain consistency among participants and reduced variability in treatment exposure.\u003c/p\u003e \u003cp\u003eAdditionally, while we accounted for seasonal variations, other external factors\u0026mdash;such as hospital policies, environmental conditions, and genetic predispositions\u0026mdash;could have influenced the results. Future research should include randomized controlled trials with blinded assessments to further validate our findings.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003e This study offers new insights into neonatal umbilical cord care by comparing conventional dry care with dermatological formulations in a large prospective cohort. While Dry Care remains widely recommended, its association with longer detachment times and higher rates of bleeding and secretion invites reflection on whether it should continue to be considered the standard approach in all settings. The findings suggest that dermatological formulations may offer advantages in specific aspects of umbilical healing, such as managing secretion or bleeding, without significantly affecting the incidence of umbilical granuloma. However, no regimen proved fully effective in preventing all complications. Overall, these results support the need to revisit current umbilical care guidelines, considering whether individualized or alternative approaches could optimize outcomes. Further research is warranted to validate these findings and inform evidence-based recommendations for routine neonatal cord care.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study protocol was approved by the Ethics Committee of the Regional General Hospital \u0026ldquo;F. Miulli\u0026rdquo; (Study No. 6641; Executive Resolution No. 1563, 7 November 2016). Written informed consent to participate was obtained from the parents or legal guardians of all neonates enrolled.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for Publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll authors have read and approved the final version of the manuscript and consent to its publication. Informed consent for the publication of anonymized data was obtained from the parents or legal guardians of the neonates involved in the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of Data and Materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe datasets used and analyzed during the current study are available from the corresponding author upon reasonable request. Any data shared will comply with applicable ethical guidelines and privacy regulations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting Interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests related to this study. The study was conducted independently, without any influence from commercial entities related to the products evaluated.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research received no specific grant from any funding agency in the public, commercial, or not-for-profit sectors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; Contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIlaria Farella was responsible for conceptualization, study design, supervision, data interpretation, manuscript drafting, and project administration. Pietro Guida carried out data curation and formal statistical analysis, verified the underlying data, and reviewed the manuscript. Giuseppe Latorre contributed to methodology and validation and critically revised the manuscript for important intellectual content. Venturina Caporusso and Palma Reginella oversaw patient care, data acquisition, follow-up coordination, and procedural oversight. Domenico Martinelli, Boris Mola, Annalisa Resta, Benedetta Giannico, Ornella Amato, Fabrizia De Palma, and Sabrina Lozupone contributed to data collection, clinical management, and manuscript revision. All authors read and approved the final version of the manuscript and agree to be accountable for all aspects of the work.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe thank the medical and nursing staff of the Neonatology and Neonatal Intensive Care Unit, Regional General Hospital \u0026ldquo;F. Miulli,\u0026rdquo; for their invaluable contributions to patient care and data collection. We are also grateful to the families who participated in this study for their collaboration and trust.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare no competing interests.\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003cstrong\u003eAuthors\u0026apos; Information\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eFor correspondence and inquiries, please contact:\u003cbr\u003e\u003cstrong\u003eIlaria Farella\u003c/strong\u003e\u003cbr\u003e\u0026nbsp;Neonatology and Neonatal Intensive Care Unit,\u003cbr\u003e\u0026nbsp;Regional General Hospital \u0026quot;F. Miulli,\u0026quot; Acquaviva delle Fonti, Italy.\u003cbr\u003e\u0026nbsp;Email:
[email protected]\u003c/p\u003e\n"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eNagar H. Umbilical granuloma: a new approach to an old problem. Pediatr Surg Int. 2001;17(7):513\u0026ndash;4.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eHegazy AA. Anatomy and embryology of umbilicus in newborns: a review and clinical correlations. Front Med. 2016;10(3):271\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMullany LC, Darmstadt GL, Katz J, Khatry SK, Leclerq SC, Adhikari RK, et al. Risk of mortality subsequent to umbilical cord infection among newborns of southern Nepal: cord infection and mortality. Pediatr Infect Dis J. 2009;28(1):17\u0026ndash;20.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eBanerjee A, Jain RA, Munghate GS, Bodhanwala M, Bendre PS. Common Salt versus Silver Nitrate for the Treatment of Umbilical Granuloma in Infants: An Open-label, Single-center, Pilot Randomized Controlled Trial. J Indian Association Pediatr Surg. 2024;29(3):199\u0026ndash;203.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eNamba F, Miyahara N, Haga M, Ota E, Ikuta Y, Mamahit CG. Interventions for treating umbilical granuloma: a protocol for a systematic review and meta-analysis of randomised controlled trials. BMJ open. 2023;13(10):e076931.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eImdad A, Bautista RM, Senen KA, Uy ME, Mantaring JB 3rd, Bhutta ZA. Umbilical cord antiseptics for preventing sepsis and death among newborns. Cochrane Database Syst Rev. 2013;2013(5):Cd008635.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePezzati M, Rossi S, Tronchin M, Dani C, Filippi L, Rubaltelli FF. Umbilical cord care in premature infants: the effect of two different cord-care regimens (salicylic sugar powder vs chlorhexidine) on cord separation time and other outcomes. Pediatrics. 2003;112(4):e275.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eGras-Le Guen C, Caille A, Launay E, Boscher C, Godon N, Savagner C et al. Dry Care Versus Antiseptics for Umbilical Cord Care: A Cluster Randomized Trial. Pediatrics. 2017;139(1).\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003ePezzati M, Biagioli EC, Martelli E, Gambi B, Biagiotti R, Rubaltelli FF. Umbilical cord care: the effect of eight different cord-care regimens on cord separation time and other outcomes. Biol Neonate. 2002;81(1):38\u0026ndash;44.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eZupan J, Garner P, Omari AA. Topical umbilical cord care at birth. Cochrane Database Syst Rev. 2004;2004(3):Cd001057.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eQuattrin R, Iacobucci K, De Tina AL, Gallina L, Pittini C, Brusaferro S. 70% Alcohol Versus Dry Cord Care in the Umbilical Cord Care: A Case-Control Study in Italy. Medicine. 2016;95(14):e3207.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAl-Shehri H. The Use of Alcohol versus Dry Care for the Umbilical Cord in Newborns: A Systematic Review and Meta-analysis of Randomized and Non-randomized Studies. Cureus. 2019;11(7):e5103.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eKapellen TM, Gebauer CM, Brosteanu O, Labitzke B, Vogtmann C, Kiess W. Higher rate of cord-related adverse events in neonates with dry umbilical cord care compared to chlorhexidine powder. Results of a randomized controlled study to compare efficacy and safety of chlorhexidine powder versus dry care in umbilical cord care of the newborn. Neonatology. 2009;96(1):13\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eDore S, Buchan D, Coulas S, Hamber L, Stewart M, Cowan D, et al. Alcohol versus natural drying for newborn cord care. Journal of obstetric, gynecologic, and neonatal nursing. JOGNN. 1998;27(6):621\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eChevenon M, Robles N, Elizer S, Ellsworth E, Pophal S, Sabati A. Multiple Giant Coronary Artery Aneurysms in a Pediatric Patient with Granulomatosis with Polyangiitis. Pediatr Cardiol. 2022;43(6):1392\u0026ndash;5.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eL\u0026oacute;pez-Medina MD, L\u0026oacute;pez-Araque AB, Linares-Abad M, L\u0026oacute;pez-Medina IM. Umbilical cord separation time, predictors and healing complications in newborns with dry care. PLoS ONE. 2020;15(1):e0227209.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMugford M, Somchiwong M, Waterhouse IL. Treatment of umbilical cords: a randomised trial to assess the effect of treatment methods on the work of midwives. Midwifery. 1986;2(4):177\u0026ndash;86.\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eMullany LC, Faillace S, Tielsch JM, Stolzfus RJ, Nygaard KE, Kavle JA et al. Incidence and risk factors for newborn umbilical cord infections on Pemba Island, Zanzibar, Tanzania. The Pediatric infectious disease journal. 2009;28(6):503\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":true,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"italian-journal-of-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"itjp","sideBox":"Learn more about [Italian Journal of Pediatrics](http://ijponline.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ITJP/default.aspx","title":"Italian Journal of Pediatrics","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Neonatal umbilical cord care, umbilical granuloma, umbilical cord complications","lastPublishedDoi":"10.21203/rs.3.rs-7879810/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7879810/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cb\u003eBackground\u003c/b\u003e\u003c/p\u003e \u003cp\u003eUmbilical granuloma (UG) is a common neonatal condition resulting from excessive granulation tissue at the umbilical stump, often leading to prolonged secretion and minor bleeding. While silver nitrate cauterization remains the standard treatment, there is growing interest in preventive approaches. This study compares different umbilical cord care regimens\u0026mdash; Dry Care, Connettivina Silver Plus Spray\u0026reg;, Cliaxin Spray\u0026reg;, or Cicaben Powder\u0026reg;\u0026mdash;focusing on umbilical detachment time and associated complications.\u003c/p\u003e\u003cp\u003e\u003cb\u003eMethods\u003c/b\u003e\u003c/p\u003e \u003cp\u003eA prospective study was conducted from November 2020 to February 2022 at the Neonatology Department of the Regional General Hospital \"F. Miulli,\" enrolling 1.699 neonates. Participants were assigned to one of four umbilical care regimens: Dry Care, Connettivina Silver Plus Spray, Cliaxin Spray, or Cicaben Powder. Treatment was administered in the hospital, and post-discharge follow-up on detachment time, bleeding, secretion, and UG formation were conducted on postnatal day 30. Statistical analyses included ANOVA and chi-square tests, with significance set at \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05.\u003c/p\u003e\u003cp\u003e\u003cb\u003eResults\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThe shortest detachment time was observed in the Cliaxin Spray group (6.5\u0026thinsp;\u0026plusmn;\u0026thinsp;2.2 days, \u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05), while Dry Care had the longest (8.0\u0026thinsp;\u0026plusmn;\u0026thinsp;2.8 days). UG incidence ranged from 4.7% to 7.8%, with no statistically significant differences between groups. Bleeding and umbilical discharge rates were significantly lower in the Cicaben Powder group (9.1% and 5.5%, respectively) compared to other regimens (\u003cem\u003ep\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05). No cases of omphalitis or sepsis occurred in any group.\u003c/p\u003e\u003cp\u003e\u003cb\u003eConclusion\u003c/b\u003e\u003c/p\u003e \u003cp\u003eThis study compared Dry Care with dermatological formulations in a large prospective cohort. Cliaxin Spray was linked to faster cord detachment, while Cicaben Powder reduced bleeding and secretion. Although Dry Care remains common, it was associated with more minor complications. No regimen fully prevented all issues, but findings suggest current guidelines should be revisited, considering more individualized approaches. Further controlled studies are needed to confirm these results.\u003c/p\u003e","manuscriptTitle":"Neonatal Umbilical Cord Treatment: A Prospective Study on Detachment Time and Complications With Different Topical Approaches","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-01-16 10:48:28","doi":"10.21203/rs.3.rs-7879810/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Major revision","date":"2026-03-24T17:19:58+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2026-02-01T17:22:40+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2026-01-12T23:33:50+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-24T00:53:05+00:00","index":"","fulltext":""},{"type":"submitted","content":"Italian Journal of Pediatrics","date":"2025-10-22T04:33:13+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
[email protected]","identity":"italian-journal-of-pediatrics","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"itjp","sideBox":"Learn more about [Italian Journal of Pediatrics](http://ijponline.biomedcentral.com)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/ITJP/default.aspx","title":"Italian Journal of Pediatrics","twitterHandle":"@BioMedCentral","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"78a5d4c4-e16b-4d97-8c5f-0e93872d001d","owner":[],"postedDate":"January 16th, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-05-06T20:01:48+00:00","versionOfRecord":[],"versionCreatedAt":"2026-01-16 10:48:28","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7879810","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7879810","identity":"rs-7879810","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}
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