]>
IRCT20241104063588N2 IRCT 2025-05-31 Jinnah Postgraduate Medical Center (JPMC) comparison of post cesarean wound infection with or without use of hydrogen peroxide during cesarean wound cleaning CHIP Trial comparison of post cesarean wound infection with or without use of hydrogen peroxide during cesarean wound cleaning 2024-01-01 anticipated 204 Complete https://irct.ir/trial/83916 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Simple randomization was used, and the unit of randomization was the individual participant. A computer-generated random number sequence was created using a randomization software to assign participants into two groups: Group A (hydrogen peroxide) and Group B (normal saline). No stratified or block randomization was applied. The random sequence was generated prior to participant enrollment to avoid selection bias. Allocation was concealed using sequentially numbered, opaque, sealed envelopes prepared by a third party not involved in participant recruitment or intervention administration. The envelopes were opened only after a participant was deemed eligible and consented to participate. This process ensured proper allocation concealment and minimized allocation bias. N/A Post-cesarean wound infection and delayed wound healing are common complications following cesarean section. These conditions contribute to increased maternal morbidity, prolonged hospital stays, and higher healthcare costs. This study focuses on evaluating methods to reduce surgical site infections and promote faster wound recovery in postpartum women.. Intervention 1: Intervention group: Intervention group: Participants received wound irrigation with 3% hydrogen peroxide solution immediately after cesarean section and before skin closure. The procedure was performed intraoperatively under sterile conditions, and the wounds were subsequently monitored for healing and infection over four weeks. Intervention 2: Control group: Control group: Participants received wound irrigation with normal saline solution immediately after cesarean section and before skin closure. The procedure was performed intraoperatively under sterile conditions, and the wounds were subsequently monitored for healing and infection over four weeks. Yes - There is a plan to make this available What will be shared: 1. Deidentified Individual Participant Data Set (IPD): Title: Deidentified Participant Dataset for Post-Cesarean Wound Healing and Infection Outcomes Details: This dataset will include deidentified information for all participants enrolled in the trial, including group allocation, age, BMI, comorbidities, cesarean type, wound healing time, and wound infection status. The dataset will be shared in Excel or CSV format and will not contain any personal identifiers. 2. Study Protocol: Title: Study Protocol – Comparison of Hydrogen Peroxide vs Normal Saline in Cesarean Wound Irrigation Details: The full study protocol including background, objectives, methodology, inclusion/exclusion criteria, intervention details, outcome measures, and statistical analysis plan. 3. Statistical Analysis Plan: Title: Statistical Analysis Plan – Cesarean Wound Infection Study Details: This document will describe the statistical tests used (e.g., chi-square test, logistic regression), data handling methods, and software (SPSS v21) used to analyze primary and secondary outcomes. 4. Informed Consent Form: Title: Informed Consent Form – Hydrogen Peroxide vs Saline Wound Irrigation Trial Details: English version of the consent form used to obtain written informed consent from participants, outlining study purpose, procedures, risks, and confidentiality. 5. Clinical Study Report: Title: Final Clinical Study Report – Post-Cesarean Wound Healing Trial Details: The full study report summarizing methodology, results, interpretation, tables, and references, as prepared for publication. 6. Data Dictionary: Title: Data Dictionary for Deidentified Participant Dataset Details: This file will explain variable names, coding schemes, value ranges, and definitions corresponding to the shared dataset to aid in interpretation by external researchers. When: The data and documents will become available six months after publication of the study results and will remain accessible for a minimum period of five years. Researchers may request access to the shared files during this time for secondary analyses or validation studies. To whom: The deidentified IPD and supporting documents will be made available to qualified researchers affiliated with academic institutions, healthcare organizations, or research institutions. Requests from individuals in non-academic settings may also be considered if the proposed use is scientifically valid and ethically appropriate. Conditions: Data and documents will be shared for the purpose of academic research, secondary data analysis, or systematic reviews/meta-analyses related to wound care, infection prevention, or obstetric surgical outcomes. Interested researchers must submit a brief proposal outlining the study objectives, methodology, and intended use of the data. Requests will be reviewed by the principal investigator and research team at Jinnah Postgraduate Medical Centre to ensure ethical compliance and scientific validity. Upon approval, data will be shared via secure email or institutional repository under a data-sharing agreement. Where to obtain: Requests for data and documents can be made by contacting the Principal Investigator, Dr. Bisma, via email at shaikhsahab553195@gmail.com. Preferred communication is through email. The recruitment center address is Jinnah Postgraduate Medical Centre, Rafiqui Shaheed Road, Cantt Area, Saddar Town, Karachi, Sindh, 75510, Pakistan. For any additional queries, contact can also be made via telephone at +92 21 99201300. How to obtain: Researchers interested in accessing the data or documents must submit a formal request via email to shaikhsahab553195@gmail.com, including a brief research proposal outlining the objectives, methodology, and intended use of the data. The request will be reviewed by the Principal Investigator and research team at Jinnah Postgraduate Medical Centre. The review process typically takes 2 to 4 weeks. If approved, the requester will be asked to sign a data-sharing agreement to ensure confidentiality and appropriate data use. After agreement, the data or documents will be shared electronically via secure means. Comments:
public Dr Bisma
Rafiqui Shaheed Road, Cantt Area, Saddar Town, Karachi, Sindh, Pakistan
Karachi Pakistan 75510 +92 331 3032992 shaikhsahab553195@gmail.com Jinnah Postgraduate Medical Centre scientific Dr Bisma
Rafiqui Shaheed Road, Cantt Area, Saddar Town, Karachi, Sindh, Pakistan
Karachi Pakistan 75510 +92 331 3032992 shaikhsahab553195@gmail.com Jinnah Postgraduate Medical Centre Pakistan Women aged between 18 and 40 years. Undergoing elective or emergency cesarean section. Gestational age greater than 36 weeks. Able and willing to provide informed consent. Agreed to attend postoperative follow-up visits for four weeks. No known allergy to hydrogen peroxide or normal saline. Hemodynamically stable after cesarean delivery. 18 years 40 years Female Known hypersensitivity or allergy to hydrogen peroxide. Presence of chronic systemic diseases (e.g., chronic obstructive pulmonary disease, stroke, renal or hepatic impairment, malignancies). Patients with ongoing infections at the time of cesarean section. Immunocompromised individuals (e.g., HIV positive, on immunosuppressive therapy). Women with hemodynamic instability postoperatively. Patients with hematological disorders affecting wound healing. Inability to provide informed consent. Refusal or inability to attend follow-up visits for four weeks. O86.0 Infection of obstetric surgical wound Treatment - Other Treatment - Other Intervention group: Intervention group: Participants received wound irrigation with 3% hydrogen peroxide solution immediately after cesarean section and before skin closure. The procedure was performed intraoperatively under sterile conditions, and the wounds were subsequently monitored for healing and infection over four weeks. Control group: Control group: Participants received wound irrigation with normal saline solution immediately after cesarean section and before skin closure. The procedure was performed intraoperatively under sterile conditions, and the wounds were subsequently monitored for healing and infection over four weeks. Incidence of post-cesarean wound infection, defined by clinical signs such as pus discharge, inflammation, deep tissue involvement, or hematoma requiring aspiration, assessed weekly for four weeks after surgery. Timepoint: 48 hours, 1 week, 2 weeks, 3 weeks, and 4 weeks after intervention. Method of measurement: Clinical examination using predefined criteria including presence of pus, redness, swelling, warmth, deep tissue involvement, or hematoma requiring aspiration, performed by trained healthcare professionals during follow-up visits. Wound healing time, categorized as early (<7 days), moderate (7–9 days), or delayed (>9 days), assessed weekly over a four-week postoperative period. Timepoint: 1 week, 2 weeks, 3 weeks, and 4 weeks after intervention. Method of measurement: Clinical assessment of wound healing by trained healthcare professionals, based on visual inspection and categorized as healed within <7 days, 7–9 days, or >9 days, recorded during weekly follow-up visits. Jinnah Postgraduate Medical Center (JPMC) Approved 2024-01-01 Jinnah Postgraduate Medical Centre, Karachi Rafiqui Shaheed Road, Cantt Area, Saddar, Karachi, Sindh, Pakistan Karachi Sindh Pakistan