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

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.

Conditions

• Appendicitis
• Surgical Wound Infection
• Postoperative Complications
• Wound Healing

Interventions

PROCEDURE

Primary Closure with HIEDI

Following open appendectomy for complicated appendicitis, the surgical wound undergoes the High-Efficiency Incision and Drainage with Irrigation (HIEDI) protocol: meticulous debridement of wound edges and pulsatile high-pressure irrigation with a minimum of 500 mL of povidone-iodine solution (1:10 dilution). All layers of the surgical wound, including the skin, are closed at the time of the initial surgery using standard techniques.

PROCEDURE

Delayed Primary Closure with HIEDI

Following open appendectomy for complicated appendicitis, the surgical wound undergoes the High-Efficiency Incision and Drainage with Irrigation (HIEDI) protocol: meticulous debridement of wound edges and pulsatile high-pressure irrigation with a minimum of 500 mL of povidone-iodine solution (1:10 dilution). The deep fascial layers are closed; the subcutaneous tissue and skin are left open, packed with saline-soaked gauze, and covered. The wound is closed at the bedside 3-5 days postoperatively if no signs of infection are present.

Sponsors & Collaborators

• Sana'a University

  lead OTHER

Principal Investigators

• Dr. Yasser Abdurabo Obadiel, Associate Professor · Faculty of Medicine and Health Sciences, Sana'a University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

12 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-07-01

Primary Completion

2026-11-30

Completion

2026-11-30

Countries

• Yemen

Study Locations