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

NCT07688109 | Not Yet Recruiting DMC

• 1 other identifier: HIEDI-APP-2026-SANA
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 3

Brief 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

Postoperative Complications; Wound Healing; Appendicitis; Surgical Wound Infection

Keywords

Complicated appendicitis; Primary wound closure; Delayed primary closure; Surgical Site Infection; HIEDI technique; Wound decontamination; Appendectomy; Yemen; Randomized controlled trial; High-Efficiency Incision and Drainage with Irrigation

Outcome Measures

Primary Outcomes (1)

• Incidence of Surgical Site Infection (SSI) at 30 Days

  Surgical Site Infection (SSI) diagnosed according to Centers for Disease Control and Prevention (CDC) criteria, classified as superficial incisional, deep incisional, or organ/space infection. Assessed by trained outcome assessors blinded to treatment allocation.

  Up to 30 days postoperatively

Secondary Outcomes (5)

• Objective Wound Healing Trajectory (ASEPSIS Score)

  Day 7, Day 14, and Day 30 postoperatively

• Length of Hospital Stay (days)

  From admission to discharge, assessed up to 30 days

• Incidence of Other Postoperative Complications

  Up to 30 days postoperatively

• Patient Satisfaction Score (0-100 scale)

  Day 7, Day 14, Day 30

• Health-Related Quality of Life (EQ-5D-5L score)

  Day 7, Day 14, Day 30

Study Arms (2)

Primary Closure with HIEDI

EXPERIMENTAL

Participants undergo open appendectomy for complicated appendicitis followed by the High-Efficiency Incision and Drainage with Irrigation (HIEDI) protocol. All wound layers including skin are closed at the time of initial surgery using the Primary Closure (PC) technique. Target enrollment: 100 participants.

Procedure: Primary Closure with HIEDI

Delayed Primary Closure with HIEDI

ACTIVE COMPARATOR

Participants undergo open appendectomy for complicated appendicitis followed by the High-Efficiency Incision and Drainage with Irrigation (HIEDI) protocol. Deep fascial layers are closed; subcutaneous tissue and skin are left open, packed with saline-soaked gauze, and closed at the bedside 3-5 days postoperatively if no infection signs are present using the Delayed Primary Closure (DPC) technique. Target enrollment: 100 participants.

Procedure: Delayed Primary Closure with HIEDI

Interventions

Primary Closure with HIEDI PROCEDURE

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.

Primary Closure with HIEDI

Delayed Primary Closure with HIEDI PROCEDURE

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.

Delayed Primary Closure with HIEDI

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Sana'a University: lead

Study Sites (3)

Al-Gumhori Teaching Hospital

Sanaa, Yemen

Location

Al-Kuwaint University Hospital

Sanaa, Yemen

Location

Al-Thawra Modern General Hospital

Sanaa, Yemen

Location

MeSH Terms

Conditions

Appendicitis; Surgical Wound Infection; Postoperative Complications

Condition Hierarchy (Ancestors)

Intraabdominal Infections; Infections; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Cecal Diseases; Intestinal Diseases; Wound Infection; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dr. Yasser Abdurabo Obadiel, Associate Professor

  Faculty of Medicine and Health Sciences, Sana'a University

  STUDY DIRECTOR

Central Study Contacts

Dr. Abdulla Salem Faraj, M.D.

CONTACT

+967770378499; a770378499@gmail.com

Dr. Yasser Abdurabo Obadiel, Associate Professor

CONTACT

+967770378499; Yasser.Obadiel@su.edu.ye

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Due to the visible nature of the surgical interventions, blinding of surgeons and patients is not feasible. Outcome assessors evaluating Surgical Site Infection (SSI), data analysts, and laboratory personnel processing wound cultures are blinded to treatment allocation. Group assignments are coded as Group A and Group B until primary analysis is complete.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Prospective, multicenter, parallel-group, 1:1 randomized controlled superiority trial. Computer-generated block randomization (variable block sizes 4, 6, 8) stratified by hospital site. Allocation concealment via sequentially numbered, opaque, sealed envelopes (SNOSE) opened in the operating room only after intraoperative confirmation of eligibility and informed consent.

Study Record Dates

• First Submitted: June 27, 2026
• First Posted: July 7, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): November 30, 2026
• Last Updated: July 7, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

YE (3)