Primary Versus Delayed Wound Closure in Complicated Appendectomy (The HIEDI-Yemen Trial) (NCT07688109) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Primary Versus Delayed Wound Closure in Complicated Appendectomy (The HIEDI-Yemen Trial)
Yemen200 participantsStarted 2026-07-01
Plain-language 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.
Who can participate
Age range
12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is comparing two different ways of closing a wound after a complicated appendectomy — closing it right away versus leaving it open temporarily — so which approach is my surgeon currently using, and how does their choice affect my risk of wound infection?
2Since this trial is not yet recruiting, it isn't an option for me right now — are there any currently active studies or established guidelines my surgeon follows that address the same question of primary versus delayed wound closure after a complicated appendectomy?
3The trial is measuring surgical site infection rates at 30 days after surgery, which suggests this is a real concern after complicated appendectomies — how likely am I to develop a wound infection given my specific situation, and what signs should I watch for at home?
4This trial involves 'complicated' appendectomy cases, such as perforated or gangrenous appendicitis — does my diagnosis fall into that category, and does that change the wound closure decision my surgeon would make?
5Since this is listed as Phase NA, meaning it's a surgical technique comparison rather than a drug trial, what does my surgeon personally believe is the safer closure method based on current evidence, and would they change their approach depending on what this kind of study eventually finds?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Surgical Site Infection (SSI) at 30 Days