AppendicitisHIEDI-YemenNCT07688109
Primary Versus Delayed Wound Closure in Complicated Appendectomy (The HIEDI-Yemen Trial)
A study testing Primary Closure with HIEDI and Delayed Primary Closure with HIEDI in people with Appendicitis and Surgical Wound Infection, run by Sana'a University at 3 sites in Yemen.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Appendicitis, Surgical Wound Infection, Postoperative Complications
- What is being tested?
- Primary Closure with HIEDI and Delayed Primary Closure with HIEDI
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 3 sitesYemen
- Study dates
- 1 Jul 2026to 30 Nov 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Yemen3 sites
Al-Gumhori Teaching Hospital
Sanaa
Dr. Abdulla Salem Faraj, M.D., +967770378499, a770378499@gmail.com
Dr. Yasser Abdurabo Obadiel, Associate Professor, +967770378499, Yasser.Obadiel@su.edu.ye
Al-Kuwaint University Hospital
Sanaa
Dr. Abdulla Salem Faraj, M.D., +967770378499, a770378499@gmail.com
Dr. Yasser Abdurabo Obadiel, Associate Professor, +967770378499, Yasser.Obadiel@su.edu.ye
Al-Thawra Modern General Hospital
Sanaa
Dr. Abdulla Salem Faraj, M.D., +967770378499, a770378499@gmail.com
Dr. Yasser Abdurabo Obadiel, Associate Professor, +967770378499, Yasser.Obadiel@su.edu.ye
About this study
Official title: 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:
Read more
- 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.
Read the detailed description
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.
- Being tested
- Primary Closure with HIEDI, Delayed Primary Closure with HIEDI
- Keywords
- Complicated appendicitis, Primary wound closure, Delayed primary closure, Surgical Site Infection, HIEDI technique, Wound decontamination, Appendectomy, Yemen, Randomized controlled trial, High-Efficiency Incision and Drainage with Irrigation
- Medical subject headings
- Appendicitis, Surgical Wound Infection, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Closure with HIEDIProcedure or surgery
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.
Delayed Primary Closure with HIEDIProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Primary Closure with HIEDI | Experimental | 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. Receives: Procedure: Primary Closure with HIEDI |
| Delayed Primary Closure with HIEDI | Active comparator | 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. Receives: Procedure: Delayed Primary Closure with HIEDI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Surgical Site Infection (SSI) at 30 Days
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.
Measured: Up to 30 days postoperatively
Secondary outcomes (5)
Objective Wound Healing Trajectory (ASEPSIS Score)
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.
Measured: Day 7, Day 14, and Day 30 postoperatively
Length of Hospital Stay (days)
Total number of days from hospital admission to discharge. Shorter stays indicate more efficient recovery.
Measured: From admission to discharge, assessed up to 30 days
Incidence of Other Postoperative Complications
Incidence of wound dehiscence, intra-abdominal abscess, hematoma, seroma, and need for reintervention. Binary (yes/no) for each complication.
Measured: Up to 30 days postoperatively
Patient Satisfaction Score (0-100 scale)
Overall satisfaction with surgical care and recovery measured on a 0-100 scale using a study-specific validated questionnaire. Higher scores indicate greater satisfaction.
Measured: Day 7, Day 14, Day 30
Health-Related Quality of Life (EQ-5D-5L score)
Health-related quality of life assessed using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) questionnaire. Higher scores indicate better quality of life.
Measured: Day 7, Day 14, Day 30
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start1 Jul 2026 (estimated)
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AppendicitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Prospective, multicenter, parallel-group, 1:1 randomized controlled superiority trial. Computer-generated block randomization (variable block sizes 4, 6, 8) stratified by hospital site. Allocation concealment via sequentially numbered, opaque, sealed envelopes (SNOSE) opened in the operating room only after intraoperative confirmation of eligibility and informed consent.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sana'a University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haitham Mohammed Jowah, Sana'a University
- Investigators
- Dr. Yasser Abdurabo Obadiel, Associate Professor, Study director, Faculty of Medicine and Health Sciences, Sana'a University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688109
- Sponsor's protocol ID
- HIEDI-APP-2026-SANA
- Acronym
- HIEDI-Yemen
- Status last verified
- Jul 2026
- First submitted
- 27 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.