Appendicitis, Postoperative Complications, Surgical Wound Infection, Wound Healing
Conditions
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
Brief 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, 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.
Interventions
PROCEDUREPrimary 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.
PROCEDUREDelayed 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.
Sponsors
Sana'a University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Surgical Site Infection (SSI) at 30 Days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Wound Healing Trajectory (ASEPSIS Score) | 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. |
| Length of Hospital Stay (days) | From admission to discharge, assessed up to 30 days | Total number of days from hospital admission to discharge. Shorter stays indicate more efficient recovery. |
| Incidence of Other Postoperative Complications | Up to 30 days postoperatively | Incidence of wound dehiscence, intra-abdominal abscess, hematoma, seroma, and need for reintervention. Binary (yes/no) for each complication. |
| Patient Satisfaction Score (0-100 scale) | 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. |
| Health-Related Quality of Life (EQ-5D-5L score) | 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. |
Countries
Yemen
Contacts
CONTACTDr. Abdulla Salem Faraj, M.D.
CONTACTDr. Yasser Abdurabo Obadiel, Associate Professor
STUDY_DIRECTORDr. Yasser Abdurabo Obadiel, Associate Professor
Faculty of Medicine and Health Sciences, Sana'a University
Outcome results
None listed