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

Starting soon · Not applicable

Conditions studied: Appendicitis, Surgical Wound Infection, Postoperative Complications, Wound Healing

In brief

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.

Key facts

Study ID

NCT07688109

Run by

Sana'a University

People needed

200

Starts

2026-07-01

Expected to finish

2026-11-30

Last updated by the study team

2026-07-07

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 12 years and older
• Intraoperative diagnosis of complicated appendicitis (perforation or gangrene)
• Undergoing open appendectomy via McBurney or Rocky-Davis incision
• Ability to provide written informed consent (patient or legal guardian for minors)
• Availability for 30-day follow-up

You may not qualify if…

• Generalized peritonitis requiring midline laparotomy
• Immunocompromised status (e.g., chronic corticosteroid or immunosuppressive therapy, diagnosed HIV infection)
• Poorly controlled diabetes mellitus (Hemoglobin A1c [HbA1c] greater than 8%)
• Pregnancy
• Concurrent malignancy
• American Society of Anesthesiologists (ASA) physical status classification IV or V
• Laparoscopic appendectomy

Where it is running

• Al-Gumhori Teaching Hospital — Sanaa, Yemen
• Al-Kuwaint University Hospital — Sanaa, Yemen
• Al-Thawra Modern General Hospital — Sanaa, Yemen

Full record on ClinicalTrials.gov

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