Primary Versus Delayed Wound Closure in Complicated Appendectomy (The HIEDI-Yemen Trial)
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12+
SponsorSana'a University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Primary Closure with HIEDI
Procedure/SurgeryFollowing 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.
Delayed Primary Closure with HIEDI
Procedure/SurgeryFollowing 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.
Treatment groups
200 Participants
are divided into 2 treatment groupsGroup A: Primary Closure with HIEDIExperimental treatment 1 intervention
Group B: Delayed Primary Closure with HIEDIActive comparator 1 intervention
Trial outcomes
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.
Time frame
Up to 30 days postoperativelySecondary outcomes
1
Objective Wound Healing Trajectory (ASEPSIS Score)
Objective assessment of wound healing and surgical site infection using the standardized ASEPSIS scoring system (evaluating criteria including erythema, serous discharge, purulent exudate, and separation of tissues). Lower scores represent superior healing.
Time frame
Day 7, Day 14, and Day 30 postoperatively2
Length of Hospital Stay (days)
Total number of days from hospital admission to discharge. Shorter stays indicate more efficient recovery.
Time frame
From admission to discharge, assessed up to 30 days3
Incidence of Other Postoperative Complications
Incidence of wound dehiscence, intra-abdominal abscess, hematoma, seroma, and need for reintervention. Binary (yes/no) for each complication.
Time frame
Up to 30 days postoperatively4
Patient Satisfaction Score (0-100 scale)
Overall satisfaction with surgical care and recovery measured on a 0-100 scale using a study-specific validated questionnaire. Higher scores indicate greater satisfaction.
Time frame
Day 7, Day 14, Day 30Sponsors and contacts
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Source ClinicalTrials.gov
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