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
- Are there results?
- Not yet: the study is under way
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.
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07688109
- Acronym / sponsor ID
- HIEDI-Yemen / HIEDI-APP-2026-SANA
- Keywords
- Complicated appendicitis, Primary wound closure, Delayed primary closure, Surgical Site Infection, HIEDI technique, Wound decontamination, Appendectomy, Yemen
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sana'a UniversityUniversity, hospital or other
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 7 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Primary Closure with HIEDI | Experimental | Procedure: Primary Closure with HIEDIParticipants 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. |
| Delayed Primary Closure with HIEDI | Active comparator | Procedure: Delayed Primary Closure with HIEDIParticipants 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Closure with HIEDIFollowing 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. | Procedure or surgery | Primary Closure with HIEDI |
| Delayed Primary Closure with HIEDIFollowing 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. | Procedure or surgery | Delayed Primary Closure with HIEDI |
Primary outcome
Incidence of Surgical Site Infection (SSI) at 30 Days
Time frame: 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.
5 secondary outcomes
Objective Wound Healing Trajectory (ASEPSIS Score)
Time frame: Day 7, Day 14, and Day 30 postoperatively
Length of Hospital Stay (days)
Time frame: From admission to discharge, assessed up to 30 days
Incidence of Other Postoperative Complications
Time frame: Up to 30 days postoperatively
Patient Satisfaction Score (0-100 scale)
Time frame: Day 7, Day 14, Day 30
Health-Related Quality of Life (EQ-5D-5L score)
Time frame: Day 7, Day 14, Day 30
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Yasser Abdurabo Obadiel, Associate Professor study director
Faculty of Medicine and Health Sciences, Sana'a University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Yemen. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Abdulla Salem Faraj, M.D. (+967770378499, a770378499@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Surgical Site Infection (SSI) at 30 Days (time frame: Up to 30 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.