A Simple Infection Prevention 'Bundle' Including Preoperative Bath With Hair-Wash to Reduce Surgical Site Infection (SSI) Following Elective Caesarean and Gynaecological Surgery in India.

Surgical site infections (SSI) lead to increased burden on healthcare systems, besides causing distress to patients. The World Health Organization (WHO) reported SSI to be the most frequent hospital acquired infection in low- or middle-income countries (LMICs) with a pooled incidence of 11.8%.[ 1 ] The SSI rates in India were reported as 30.7% and 5.4% among clean surgeries.[ 2 ] While the global estimates of SSI vary from 0.5% to 15%, studies in India report higher rates ranging from 23% to 38%.[ 2 ] The incidence of SSI following a caesarean section (CS) ranges from 3% to 15% worldwide.[ 3 ] The SSI rate after hysterectomy was 1.7% in the USA.[ 4 5 ] In India, Shahane et al .[ 6 ] reported the SSI rate to be 6%, while Bangal et al .[ 7 ] reported it to be 2.8% in gynaecological surgeries. Pathak et al .[ 8 ] observed the SSI rate to be 7.84% among 1173 patients undergoing obstetric and gynaecologic surgeries in rural India, with a lower incidence among obstetric than gynaecologic surgeries (1.2% vs 10.3%). SSI may be prevented by following a group of pre, intra, and postoperative prevention measures or ‘bundles’.[ 9 10 ] These include adequate glycaemic control, preoperative shower, preoperative cleansing of surgical site with antiseptics, preoperative antimicrobial prophylaxis, sterile surgical equipment, short duration of surgery, less blood loss, maintaining normothermia, proper oxygenation and care of incision after surgery.[ 11 12 13 ] A less frequently addressed issue is the regimen for preoperative bath or shower. A Cochrane review evaluating chlorhexidine (CHG) wipes or showers concluded that though it may reduce the microbial burden, clinical evidence of benefit was not present.[ 14 ] The CDC advises a shower or full body bath with soap (antimicrobial or non-antimicrobial) or an antiseptic agent at least the night before surgery.[ 15 ] Two sequential showers with CHG (4%), with 1-min pause before rinsing resulted in its skin surface concentration to be higher than its minimum inhibitory concentration for SSI pathogens, but whether this will translate into lower SSI rates is not known.[ 15 ] Compliance may be better with a single preoperative bath as a regimen of daily CHG bath for 5 days preoperatively was associated with a low full adherence rate of 39%.[ 10 ] The issue of washing scalp hair during a preoperative bath is not addressed specifically, though a preoperative shower is likely to include it. Among 1093 patients undergoing elective clean biliary tract, inguinal hernia and breast surgeries, a CHG shower (including scalp) a day before surgery reduced SSIs better than a partial wash restricted to surgical site.[ 14 16 ] This issue assumes importance in India, as culturally, many Indian women have long hair and use a bucket for bathing, rather than a shower. A bucket-bath may not always include scalp hair wash. Furthermore, they may have travelled from villages or small towns to big hospitals in cities for surgery. Due to lack of awareness, as well as lack of proper facility away from home, they may be unable to take a proper preoperative bath with hair wash. Unwashed scalp hair for several days may harbour SSI causing bacteria which may reach the surgical site by touching by the patient’s hands. Hence, ensuring compliance to a preoperative bath regimen may help to reduce SSI after CS and gynaecological abdominal surgery. This study was planned to see the incidence of SSI after implementing simple SSI prevention measures which included a preoperative bath with scalp hair wash among women undergoing elective CS and gynaecological surgery. As many women consult primary care physicians prior to admission to a hospital for CS or gynaecological surgery, knowledge about simple SSI prevention measures may help them to guide these women.

This study was approved and funded by the Indian Council of Medical Research, India. It was carried out from August 2018 to July 2019 after approval of the Ethics Committees of the Post Graduate Institute of Medical Education and Research, Chandigarh and Civil Hospital, Panchkula, Haryana. Women undergoing Elective CS and Elective Gynaecological abdominal surgery (hysterectomy and surgery on the ovaries or tubes for benign or malignant indications) were enrolled after an informed written consent and willingness to follow the SSI prevention measures. We excluded women with history of infection within 2 weeks prior to surgery (eg, febrile illness and urinary tract infection) or intraoperatively (pelvic or peritoneal abscess), and those needing intraoperative bowel or urinary tract surgery. Women undergoing emergency surgery (CS or laparotomy for ruptured ectopic pregnancy) were also excluded. A SSI prevention bundle checklist was prepared incorporating SSI prevention measures as advised by the WHO.[ 12 13 ] A SSI prevention measures pro forma was prepared to record clinical data, anti-microbial prophylaxis, surgical details and postoperative outcome. SSI is classified as a superficial, deep and organ space infection (CDC, 2018).[ 17 ] A pro forma to note womens’ knowledge about the SSI prevention measures was designed by a psychologist. For the first 3 months, baseline data of SSI were collected. During this period, as per hospital practice, patients were following routine SSI prevention measures advised by the doctor in-charge. During the next 9 months, the SSI prevention bundle was implemented. Women admitted for elective CS or gynaecological surgery were asked preoperatively about their knowledge and acceptability of SSI prevention measures. The 15-point knowledge assessment questionnaire assigned a score of 0 (lack of knowledge) or 1 (knowledge present) about each health related question. Women were allocated into a ‘good’ (score 11–15), ‘average’ (score 6–10) or ‘poor’ (score 0–5) category. After they had answered the questionnaire preoperatively, project staff educated them about SSI prevention measures. Thereafter, they were counselled to follow the SSI prevention bundle with emphasis on the preoperative bath regimen including scalp hair wash within 24 h preceding surgery. They were advised to use their routine soap and shampoo and to wear clean cotton clothes after bath. Bathing facilities (warm water or shower) were made available in the wards. If surgery was delayed to beyond 24 h but less than 48 h, the bath regimen (but not hair wash) was repeated. If surgery was postponed by more than 48 h, the entire bath regimen including hair wash was repeated. The SSI prevention measures followed pre-, intra- and postoperatively were noted. Details of surgery, antimicrobial surgical prophylaxis and postoperative course including temperature record and investigations were also noted. Postoperatively, knowledge and acceptability of SSI prevention measures were reassessed. The women were followed-up till discharge from hospital and for a total of 30 days, telephonically or during hospital visits. Telephone number of project staff was provided and they were asked to report in case of fever, discharge from the surgical site or any other problem. The incidence of SSI was noted, along with its treatment. In women, who developed SSI or endometritis, swabs were collected from infected area for bacterial culture and sensitivity for further management by treating consultant. The primary outcome was the change in incidence of SSI as compared with the baseline following implementation of the SSI prevention bundle among women undergoing elective CS and gynaecological abdominal surgery. The secondary outcome was to observe the knowledge, acceptability and compliance of women toward preoperative bath including scalp hair wash as a part of the SSI prevention bundle.

Figures 1 and 2 show the flowchart of recruitment of women at the two sites. Table 1 shows the demographic details of women undergoing elective CS. The mean age of women at PGI (30.3 ± 4.8 years and 29.7 ± 4.8 years) was higher than at CH (26.6 ± 3.7 years and 26.9 ± 4.4 years), and the mean BMI and haemoglobin level were similar. However, women at PGI had an overall higher education level: 53% and 43% were graduates or above as compared with 34% and 27% at CH. Although majority of the women were housewives, more women at PGI were employed as compared with CH. The most common indication for elective CS was previous CS. Adherent placenta was more common at PGI which is a tertiary hospital than at CH which is a district hospital. Flowchart of patient recruitment at baseline and during intervention in PGIMER, Chandigarh Flowchart of patient recruitment at baseline and during intervention in Civil Hospital, Panchkula, Haryana Demographic details of women undergoing Elective Caesarean Section at the two sites Table 2 shows the demographic details of women undergoing elective gynaecological abdominal surgery. The mean age of the women at PGI and CH at baseline was similar, but was higher at PGI at intervention (45.9 ± 13.6 years vs 41.3 ± 7.5 years). The mean BMI was similar, however, the mean haemoglobin of women at PGI was lower than at CH at baseline (10.9 ± 1.7 g/dl vs 12.2 ± 1.6 g/dl, P = 0.001). Women at PGI had a higher level of education: 26.7% and 33.2% were graduates or above as compared with only 3.8% and 5.1% at CH. Although majority of the women were housewives, more women at PGI were employed as compared with CH. The indications for surgery were significantly different at the two sites ( P = 0.000), with malignancy being the most common indication at PGI and fibroid uterus at CH. Demographic details of women undergoing Elective Gynaecological abdominal Surgery at the two sites Table 3 shows the incidence of SSI at baseline and during intervention. At PGI, the incidence of SSI reduced significantly during intervention as compared with baseline (11.1% to 3.7% in CS, 13% to 7.1% in gynaecological surgery). However, this reduction was not observed at CH (8.5% and 8.2% in CS and 11.5% and 11.4% in gynaecological surgery). Majority of the women had superficial SSI. At baseline, one woman at CH had organ-space SSI after hysterectomy for fibroids and had laparotomy for pelvic abscess after 3 weeks. During intervention, one woman at CH had organ space SSI after CS and had laparotomy for pyoperitoneum after 17 days. Comparison of incidence of SSI at baseline and post intervention at the two sites Tables 4 and 5 list the SSI prevention measures followed during CS and gynaecological surgery at the two sites. At PGI, there was a significant increase in the uptake of two measures during intervention as compared with baseline: preoperative bath with hair wash (CS: 50% to 93.2%, gynae surgery: 65% to 99.3%) and use of clipper instead of razor for incision-site hair removal (CS: 75% to 93.6%, gynae surgery: 74% to 100%). At CH, there was increased uptake of preoperative bath with hair wash during intervention (CS: 21% to 71%, gynae surgery: 27% to 78.5%). Also, institution of antibiotic prophylaxis ≤120 min increased (CS: 29% to 80.8%, gynae surgery: 84.6% to 92.4%). However, use of clipper for hair removal was not practiced. SSI prevention bundle checklist measures followed at baseline and after intervention among women undergoing Elective Caesarean Section at the two sites P (significant) *,**,#,## P =0.000 SSI prevention bundle checklist measures followed at baseline and after intervention among women undergoing Elective Gynaecological abdominal surgery at the two sites P (significant)*,**, # P =0.000 During intervention, three preoperative measures were followed in significantly more women at PGI than at CH. Among women undergoing CS: bath with hair-wash: 93.2% vs 71%, P = 0.000, antibiotic ≤120 min: 100% vs 80.8%, P = 0.000 and use of clipper: 93.6% vs 1.9%, P = 0.000; and among women undergoing gynaecological surgery: bath with hair-wash: 99.3% vs 78.5%, P = 0.000, antibiotic ≤120 min: 100% vs 92.4%, P = 0.000 and using clipper: 100% vs 5.1%, P = 0.000. Tables 6 and 7 show the pre- and postoperative knowledge assessment of women during intervention. Preoperatively, knowledge regarding a few practices was less and fewer than 20% women at each site were aware of pre- and postoperative bath with hair wash and its timing, pre- and postoperative exercises related to legs and breathing, postoperative ambulation and using a hair clipper instead of a razor. This questionnaire was answered again in the postoperative period and a significant improvement in the knowledge score was observed at the two sites, with about 80% having a ‘good’ score as compared with fewer than 8% in the preoperative period. Pre- and Postoperative knowledge assessment of women (at intervention) undergoing Elective Caesarean section at two sites (%) in parentheses Pre- and Postoperative knowledge assessment of women (at intervention) undergoing Elective Gynaecological abdominal surgery at two sites (%) in parentheses

To conclude, providing knowledge about simple SSI prevention measures to patients and health staff including primary care physicians will increase the compliance of patients to follow simple measures like a preoperative bath with scalp hair wash. Further, providing facilities (eg, hair clippers, showers, and clean bathrooms with warm water in wards) will improve the uptake of these measures. Finally, assigning the preoperative antibiotic prophylaxis to the anaesthesia team inside the OT (rather than given by nursing staff in ward before shifting to OT) for its optimal timing may have a role in reducing the burden of SSI. PGIMER, Chandigarh: PGI/IEC/2018/000364 dated 26.03.2018 CH, Panchkula: CH/Pkl/2018 dated 02.04.2018 PGIMER, Chandigarh: PGI/IEC/2018/000364 dated 26.03.2018 CH, Panchkula: CH/Pkl/2018 dated 02.04.2018 RB: design of study proposal, execution of study, compiling results & drafting the manuscript VS: design of study proposal, MR: execution of study and checking results MB: design of study proposal, checking results RN: design of knowledge assessment questionnaire, checking results ND: execution of study, arranging facilities like showers and hair-clippers, checking results Site 2: CH SS: execution of study, checking results AS: execution of study, checking results LJ: execution of study, checking results Study Approval: This study was approved and funded by the Indian Council of Medical Research (ICMR), India vide RBMH/NTF/SSI/2018 dated 5/7/2018 The authors certify that they have obtained all appropriate patient consent forms. In the form the patients have given their consent for their clinical information to be reported in the journal. The patients understand that their names and initials will not be published and due efforts will be made to conceal their identity, but anonymity cannot be guaranteed. This study was approved and funded by the Indian Council of Medical Research (ICMR), India vide RBMH/NTF/SSI/2018 dated 5/7/2018. There are no conflicts of interest.

In this study, we observed the incidence of SSI following an intervention in which research staff provided information about simple SSI prevention measures to women undergoing elective CS and gynaecological abdominal surgery, and encouraged their uptake by women. We also noted the SSI prevention bundle measures being followed before, during and after surgery in two hospitals in North India. During the intervention period, the SSI rate was reduced significantly at Post Graduate Institute of Medical Education and Research (PGIMER) as compared with baseline (CS: 11.1% to 3.7%, P = 0.048; gynae surgery: 13% to 7.1%, P = 0.027). However, at CH, the SSI rate during the intervention period was not reduced as compared with baseline (CS: 8.5% to 8.2%, P = 0.903; gynae surgery: 11.5% to 11.4%, P = 0.984). Our key finding was that three SSI prevention measures were followed more often at PGIMER than at CH, before CS: bath with hair-wash: 99.3% vs 78.5%, P = 0.00, using hair-clipper instead of razor for incision site hair removal: 100% vs 5.1%, P = 0.00 and antibiotic prophylaxis ≤ 120 min before incision: 100% vs 92.4%, P = 0.00, and before gynae surgery: bath with hair wash: 93.2% vs 71%, P = 0.00, hair-clipper vs razor: 93.6% vs 1.9%, P = 0.00 and antibiotic prophylaxis ≤ 120 min before incision: 100% vs 80.8%, P = 0.00. The reduction in SSI at PGI was attributed to better compliance to the abovementioned prevention measures. This may be partly due to a better education level of women at PGI, and partly as PGI is a research institute where new interventions are adopted actively. Furthermore, in CH, preoperative antibiotic is administered in ward by nurses prior to shifting to operation theatre (OT), whereas, in PGI, it is administered by anaesthetists inside the OT, which is better timed. We also observed that counselling women about SSI prevention preoperatively increased their knowledge about these significantly as evident by a higher knowledge score in the postoperative period. These simple interventions are well documented SSI prevention measures.[ 12 13 ] A preoperative bath including scalp hair wash is culturally relevant in India where most women wear long hair. Western literature advises a preoperative ‘shower’ which includes a hair wash, but this may not be so India, where most women have a bucket-bath which may not always include a hair wash.[ 10 14 15 ] Dhamecha et al .[ 18 ] observed the SSI rate among women undergoing CS and gynaecological surgery (n = 494) in a tertiary hospital at Ahmedabad, India; their overall SSI rate of 4.25% was lower than the overall SSI rate at PGI (5.8%) and at CH (8.8%). Dhamecha et al .[ 18 ] attributed a low SSI rate to surgery being performed by senior doctors as postgraduation had not yet started in their institute. In this study, surgeries were performed by medical officers in CH and by faculty and residents in PGI. A higher SSI rate (24.2%) among CS was reported by De et al .[ 19 ] in New Delhi, India, with premature rupture of membranes, inappropriate antibiotic prophylaxis, and increased duration of hospital stay as significant risk factors. Naphade and Patole[ 20 ] observed an SSI rate of 10.3% in gynaecological surgeries (n = 985) in a medical college in Maharashtra, which is similar to this study. The incidence of SSI may vary as these are multifactorial and depend on the patient load, type of hospital, and patient population. The CDC advises a shower or bath (full body) with soap (antimicrobial or non-antimicrobial) or an antiseptic agent on at least the night before to reduce SSI.[ 11 ] We advised women to use their regular soap and shampoo and the uptake of preoperative bath increased at the two sites, but it was higher at PGI than at CH. SSI prevention measures include preprocedure shower within 24 h of surgery, hair removal with clipper rather than shaving immediately before operation, antibiotic prophylaxis, proper skin preparation, good surgical technique, and covering incision site with a sterile dressing for 24 to 48 h.[ 11 21 22 ] During the intervention, compliance to hair-clipper was low at CH (CS: 1.9% and gynae surgery: 5.1%), while it was 93.6% and 100% among CS and gynae surgery at PGI. A comparison of hair removal by shaving versus clipping showed a higher risk of wound infection with shaving, as razor can lead to microlesions and colonization of skin at surgical site by microorganisms which increase the chance of postoperative infection.[ 23 24 ] Depilating creams are comparable to clippers for postoperative wound infections, though may cause skin irritation in some.[ 23 24 ] Providing knowledge about SSI prevention should be included in hospital protocols and a study in France showed that 80% patients received no information about SSI during hospitalization.[ 25 ] Our 15-point SSI prevention questionnaire showed that at each site, most women (>75%) were aware of hand hygiene, but few (<20%) were aware of a pre- or postoperative bath schedule or about legs and breathing exercises. During intervention, knowledge score improved significantly after counselling, showing good communication by research staff. Specifically, knowledge about preoperative bath and hair-wash was present in > 94% women at the two sites. However, compliance to this was present among 93.2% and 99.3% women at PGI (CS and gynae surgery, respectively) but significantly less among women at CH (71% and 78.5% in CS and gynae surgery, respectively). The possible reasons were less bathrooms (1 shower and 1 bathroom for 50 women) with erratic availability of warm water and fear of slipping in the bathroom. In PGI, one ward has three shower bathrooms for 42 women, and the other ward has 3 bathrooms for 57 women. Providing plastic stools or chairs improved compliance to bath at PGI. Hence, providing knowledge as well as proper facility may increase compliance to preoperative bath and hair wash. However, a bath on the 3 rd postoperative day was more difficult to achieve as women, their relatives and even some health providers felt that bath should after suture removal (7 th to 10 th day) only. After reviewing available evidence, the PGI faculty agreed unanimously on a bath on the 3 rd postoperative day (72 h after surgery).[ 1 26 27 28 ] During bath, the stitch line is covered with a waterproof dressing or plastic cover, which is replaced by afresh sterile dressing after bath. Motivating women for a postoperative bath in hospital makes them confident about taking it at home subsequently, or else, they avoid it till suture removal which leads to poor hygiene and may cause SSI. Although the knowledge of women about postoperative bath increased from 90% women during intervention, many women (~70%) did not take it in hospital because of their traditional beliefs. Even the response of healthcare providers toward postoperative bath in CH was not encouraging and one of them even stated ‘water is the enemy of stitches’ in vernacular language’. A study from a teaching hospital in Nepal suggested that patients require information on SSI prevention to increase their involvement in its prevention.[ 29 ] A significant decline in SSI rate from 8.6% to 2.9% was observed with a stepwise plan and bundle providing patient education and prevention measures in pre-, peri-, and postoperative period.[ 30 ] Keeping this in mind, a video was prepared incorporating evidence-based health advice for Indian women undergoing a CS.[ 1 26 27 28 ] The video is available on PGIMER website ( www.pgimer.edu.in ) and YouTube ( https://youtu.be/WSgKB3_-AjQ ). Finally, accumulation of accurate data about SSIs along with implementation of SSI prevention bundles may lower its incidence in LMICs.[ 31 32 ]