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

2. juli 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

200

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Yemen
      • Sanaa, Yemen
        • Al-Thawra Modern General Hospital
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Dr. Abdulla Salem Faraj, M.D.
      • Sanaa, Yemen
        • Al-Gumhori Teaching Hospital
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Dr. Abdulla Salem Faraj, M.D.
      • Sanaa, Yemen
        • Al-Kuwaint University Hospital
        • Kontakt:
        • Kontakt:
        • Ledende efterforsker:
          • Dr. Abdulla Salem Faraj, M.D.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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.
Procedure: 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.
Aktiv komparator: 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.
Procedure: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Incidence of Surgical Site Infection (SSI) at 30 Days
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Objective Wound Healing Trajectory (ASEPSIS Score)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Sana'a University

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

30. november 2026

Studieafslutning (Anslået)

30. november 2026

Datoer for studieregistrering

Først indsendt

27. juni 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

7. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

7. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • HIEDI-APP-2026-SANA

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

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.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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