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Primary Versus Delayed Wound Closure in Complicated Appendectomy (The HIEDI-Yemen Trial)

Study acronym: HIEDI-Yemen
StatusNot Yet Recruiting
PhaseNot applicable
Started
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Record History

  1. Minor Study First Submitted
The goal of this clinical trial is to compare primary wound closure (PC) versus delayed primary closure (DPC) after standardized wound decontamination using the High-Efficiency Incision and Drainage with Irrigation (HIEDI) technique in patients undergoing open appendectomy for complicated appendicitis in Sana'a, Yemen. The main questions it aims to answer are: * Does primary closure with HIEDI result in a non-inferior or lower incidence of Surgical Site Infection (SSI) at 30 days compared with delayed primary closure with HIEDI? * Does primary closure with HIEDI reduce length of hospital stay and improve the trajectory of objective wound healing compared with delayed primary closure with HIEDI? * What is the impact of each closure method on patient satisfaction and health-related quality of life? Researchers will compare the two groups to determine the optimal, evidence-based standard of care for wound management in complicated appendicitis within a resource-limited setting. Participants will: * Undergo open appendectomy for intraoperatively confirmed complicated appendicitis (perforation or gangrene). * Receive standardized HIEDI wound decontamination (meticulous debridement and pulsatile irrigation with minimum 500 mL povidone-iodine 1:10 solution). * Be randomly allocated to either primary closure (all layers closed at surgery) or delayed primary closure (skin/subcutaneous tissue left open and closed 3-5 days later). * Attend follow-up visits at days 7, 14, and 30 for wound assessment, infection surveillance, and outcome evaluation.
Trial Details
NCT Number NCT07688109
Lead Sponsor Sana'a University
Conditions
(from sponsor)
Appendicitis, Surgical Wound Infection, Postoperative Complications, Wound Healing
Related terms Appendicitis, Postoperative Complications, Surgical Wound Infection
Enrollment 200 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov