Clinical Trial

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

Study acronym: HIEDI-Yemen
Not Yet Recruiting
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Summary
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 Appendicitis, Surgical Wound Infection, Postoperative Complications, Wound Healing
Enrollment 200 participants
Start Date 2026-07-01
Primary Completion 2026-11-30 (estimated)
Study Completion 2026-11-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-07