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

2026년 7월 2일 업데이트: Haitham Mohammed Jowah, Sana'a University

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

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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

200

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

  • 이름: Dr. Yasser Abdurabo Obadiel, Associate Professor
  • 전화번호: +967770378499
  • 이메일: Yasser.Obadiel@su.edu.ye

연구 장소

  • 예멘
      • Sanaa, 예멘
        • Al-Thawra Modern General Hospital
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Dr. Abdulla Salem Faraj, M.D.
      • Sanaa, 예멘
        • Al-Gumhori Teaching Hospital
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Dr. Abdulla Salem Faraj, M.D.
      • Sanaa, 예멘
        • Al-Kuwaint University Hospital
        • 연락하다:
        • 연락하다:
        • 수석 연구원:
          • Dr. Abdulla Salem Faraj, M.D.

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 어린이
  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: Primary Closure with HIEDI
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.
절차: 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.
활성 비교기: Delayed Primary Closure with HIEDI
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.
절차: 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 if no signs of infection are present.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Incidence of Surgical Site Infection (SSI) at 30 Days
기간: Up to 30 days postoperatively
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

2차 결과 측정

결과 측정
측정값 설명
기간
Objective Wound Healing Trajectory (ASEPSIS Score)
기간: Day 7, Day 14, and Day 30 postoperatively
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.
Day 7, Day 14, and Day 30 postoperatively
Length of Hospital Stay (days)
기간: From admission to discharge, assessed up to 30 days
Total number of days from hospital admission to discharge. Shorter stays indicate more efficient recovery.
From admission to discharge, assessed up to 30 days
Incidence of Other Postoperative Complications
기간: Up to 30 days postoperatively
Incidence of wound dehiscence, intra-abdominal abscess, hematoma, seroma, and need for reintervention. Binary (yes/no) for each complication.
Up to 30 days postoperatively
Patient Satisfaction Score (0-100 scale)
기간: Day 7, Day 14, Day 30
Overall satisfaction with surgical care and recovery measured on a 0-100 scale using a study-specific validated questionnaire. Higher scores indicate greater satisfaction.
Day 7, Day 14, Day 30
Health-Related Quality of Life (EQ-5D-5L score)
기간: Day 7, Day 14, Day 30
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Higher scores indicate better quality of life.
Day 7, Day 14, Day 30

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Sana'a University

수사관

  • 연구 책임자: Dr. Yasser Abdurabo Obadiel, Associate Professor, Faculty of Medicine and Health Sciences, Sana'a University

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 7월 1일

기본 완료 (추정된)

2026년 11월 30일

연구 완료 (추정된)

2026년 11월 30일

연구 등록 날짜

최초 제출

2026년 6월 27일

QC 기준을 충족하는 최초 제출

2026년 7월 2일

처음 게시됨 (실제)

2026년 7월 7일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 7월 7일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 7월 2일

마지막으로 확인됨

2026년 7월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • HIEDI-APP-2026-SANA

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

IPD 계획 설명

The study team does not plan to share individual participant data with other researchers. This is a single-center thesis study with limited data management infrastructure, and the dataset contains identifiable clinical information that cannot be sufficiently de-identified for broad sharing under local ethical guidelines.

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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