Comparison of different concentrations of a povidone iodine diluted sitz bath in the prevention of perianal infection in patients undergoing chemotherapy for hematological malignancy: Study protocol for a randomized controlled trial

Abstract Background: Infection is one of the most common causes of death in patients with hematological malignancies during chemotherapy. Due to its special location, local warmth and humidity, repeated pollution with stool and urine, and characteristically wrinkled anatomical structure within which bacteria can hide, the perianal becomes a site with a high incidence of infection. Such infection also has a high recurrence rate and high mortality, increasing the economic burden of patients, delaying the time of treatment and reducing the quality of life. In severe cases, sepsis occurs and endangers the patient's life. Previous studies have confirmed the effectiveness of povidone iodine in the prevention of perianal infection in patients with hematologic malignancies during chemotherapy, but these reports have not documented in detail the adverse events associated with sitz bathing and the lack of randomized controlled trials of different concentrations of dilute povidone iodine sitz bathing. Therefore, the evidence are insufficient. Methods: In this study, we plan to include 268 patients with hematological malignancies undergoing chemotherapy who have risk factors for perianal infection. The objective is to determine whether a povidone iodine diluent sitz bath can reduce the incidence of perianal infection compared with conventional perianal cleaning care and to observe the incidence of perianal infection, the severity of perianal infection and the complications related to the sitz bath among groups treated with different concentrations of povidone iodine diluent, especially in high-risk patients prone to perianal infection, so as to screening for the optimal concentration. The primary endpoint of the trial is the incidence of perianal infection. The secondary endpoints of the study will be the results of anal swab bacterial culture, the severity of perianal infection, the incidence of perianal adverse events (dryness, peeling, pigmentation, burning sensation), and pain scores. The length of hospitalization in days and hospitalization expenses will be recorded. Safety will be assessed with consideration of all adverse and severe adverse events related to the study treatment. Discussion: This study has received full ethics committee approval. The first patient was enrolled on May 1, 2021. The results of this trial will finally answer the questions regarding the effectiveness of povidone iodine diluent sit baths in the prevention of perianal infection in patients with hematological malignancies during chemotherapy and will screen for the best concentration.Trial registration: Chinese Clinical Trial Registry (registration ID: ChiCTR2000041073).Registered on December 17, 2020. {2}http://www.chictr.org.cn/edit.aspx?pid=66044&htm=4 {2b}