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

Qualifiers

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

Treatments tested in this trial

  • Primary Closure with HIEDI
  • Delayed Primary Closure with HIEDI

Treatment groups

200 Participants
are divided into 2 treatment groups

Sponsors and collaborators