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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary Closure with HIEDI | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Up to 30 days postoperatively |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Day 7, Day 14, and Day 30 postoperatively |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Abdulla Salem Faraj, M.D. | Contact | +967770378499 | a770378499@gmail.com | |
| Dr. Yasser Abdurabo Obadiel, Associate Professor | Contact | +967770378499 | Yasser.Obadiel@su.edu.ye |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Yasser Abdurabo Obadiel, Associate Professor | Faculty of Medicine and Health Sciences, Sana'a University | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Al-Gumhori Teaching Hospital | Sanaa | Yemen |
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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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.
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Due to the visible nature of the surgical interventions, blinding of surgeons and patients is not feasible. Outcome assessors evaluating Surgical Site Infection (SSI), data analysts, and laboratory personnel processing wound cultures are blinded to treatment allocation. Group assignments are coded as Group A and Group B until primary analysis is complete.
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| Delayed Primary Closure with HIEDI | Procedure | 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. |
|
| Length of Hospital Stay (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 | 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) | 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) | 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 |
| Al-Kuwaint University Hospital | Sanaa | Yemen |
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| Al-Thawra Modern General Hospital | Sanaa | Yemen |
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| ID | Term |
|---|---|
| D001064 | Appendicitis |
| D013530 | Surgical Wound Infection |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D059413 | Intraabdominal Infections |
| D007239 | Infections |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D002429 | Cecal Diseases |
| D007410 | Intestinal Diseases |
| D014946 | Wound Infection |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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