comparison of post cesarean wound infection with or without use of hydrogen peroxide during cesarean wound cleaning

The aim of this study is to compare the effectiveness of hydrogen peroxide versus normal saline irrigation in reducing post-cesarean wound infections and promoting faster wound healing.

Randomised, open-label, parallel group controlled trial conducted at a single tertiary care center with a total sample size of 204 participants. Participants were randomly assigned in a 1:1 ratio using a computer-generated sequence to receive either hydrogen peroxide or normal saline wound irrigation. The study was not blinded, and outcome assessment was based on predefined clinical criteria.

The trial was conducted at the Department of Obstetrics and Gynecology, JPMC Karachi, over six months. Women undergoing cesarean section were randomized to receive either 3% hydrogen peroxide or normal saline for wound irrigation. Follow-up continued for four weeks to assess wound healing and infection using standardized clinical criteria. The study was open-label with no blinding.

Women aged 18–40 years undergoing cesarean section at >36 weeks and hemodynamically stable were included. Exclusion criteria included chronic illness, active infection, immunocompromised state, or allergy to hydrogen peroxide.

Participants were randomly assigned to one of two groups. Group A received 3% hydrogen peroxide irrigation of the surgical wound before closure during cesarean section. Group B received normal saline irrigation of the wound before closure. Both groups were followed postoperatively for four weeks to assess wound healing and infection rates.

Main outcomes were wound healing time and post-cesarean wound infection. Healing was monitored weekly for four weeks and categorized by duration. Infection was defined by clinical signs such as pus, inflammation, or hematoma.

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.

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.

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.

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.

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.

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.

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.