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

Официальное название

A Comparative Study of Primary Versus Delayed Wound Closure Using the High-Efficiency Incision and Drainage With Irrigation (HIEDI) Technique to Minimize Surgical Site Infection (SSI) Risk in Patients Undergoing Complicated Appendectomy

Обзор

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.

Подробное описание

Complicated appendicitis (perforation or gangrene) is a significant cause of postoperative morbidity worldwide. Surgical Site Infection (SSI) is the most common complication, with reported rates exceeding 30% in low- and middle-income countries (LMICs). In Sana'a, Yemen, local data from Al-Thawra Modern General Hospital documented a 27.5% SSI rate specifically in this patient population. The optimal wound closure strategy-primary closure (PC) versus delayed primary closure (DPC)-remains debated, with previous studies yielding conflicting results largely due to lack of standardized intraoperative wound decontamination.

The High-Efficiency Incision and Drainage with Irrigation (HIEDI) technique is a standardized, aggressive decontamination protocol combining meticulous debridement of wound edges with pulsatile high-pressure irrigation using a minimum of 500 mL of povidone-iodine solution (1:10 dilution). By applying HIEDI uniformly to both study arms, this trial isolates the effect of closure timing on SSI risk.

This is a prospective, multicenter, parallel-group, 1:1 randomized controlled superiority trial with blinded outcome assessment, conducted at three tertiary care hospitals in Sana'a, Yemen. The findings will provide high-level, locally generated evidence to establish a safe, resource-conscious standard of care for Yemen and similar settings.

Вмешательства

• Процедура 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.
• Процедура 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

Первичные конечные точки

• Incidence of Surgical Site Infection (SSI) at 30 Days [Срок оценки: Up to 30 days postoperatively]

Вторичные конечные точки (5)

• Objective Wound Healing Trajectory (ASEPSIS Score) [Срок оценки: Day 7, Day 14, and Day 30 postoperatively]
• Length of Hospital Stay (days) [Срок оценки: From admission to discharge, assessed up to 30 days]
• Incidence of Other Postoperative Complications [Срок оценки: Up to 30 days postoperatively]
• Patient Satisfaction Score (0-100 scale) [Срок оценки: Day 7, Day 14, Day 30]
• Health-Related Quality of Life (EQ-5D-5L score) [Срок оценки: Day 7, Day 14, Day 30]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Yemen · 3 центра

• Al-Gumhori Teaching Hospital — Sanaa
• Al-Kuwaint University Hospital — Sanaa
• Al-Thawra Modern General Hospital — Sanaa

Идентификаторы

NCT: NCT07688109 · HIEDI-APP-2026-SANA

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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