[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646757":3},{"organization":4,"outcomesModule":7,"designInfo":33,"detailedDescription":43,"studyPopulation":32,"armGroups":44,"interventions":57,"overallOfficials":65,"centralContacts":70,"locations":78,"responsibleParty":113,"collaborators":32,"id":116,"slug":117,"hasResults":118,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":122,"eligibilityCriteria":123,"healthyVolunteers":118,"sex":124,"minAge":125,"maxAge":32,"enrollmentInfo":126,"targetDuration":32,"studyType":129,"phases":130,"briefSummary":132,"conditions":133,"keywords":138,"overallStatus":148,"whyStopped":32,"lastUpdateSubmitDate":149,"lastUpdatePostDateStruct":150,"startDateStruct":153,"completionDateStruct":155,"leadSponsor":157,"locationsCount":158},{"fullName":5,"class":6},"Sana'a University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":32},[9],{"measure":10,"description":11,"timeFrame":12},"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\u002Fspace infection. Assessed by trained outcome assessors blinded to treatment allocation.","Up to 30 days postoperatively",[14,18,22,25,29],{"measure":15,"description":16,"timeFrame":17},"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",{"measure":19,"description":20,"timeFrame":21},"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",{"measure":23,"description":24,"timeFrame":12},"Incidence of Other Postoperative Complications","Incidence of wound dehiscence, intra-abdominal abscess, hematoma, seroma, and need for reintervention. Binary (yes\u002Fno) for each complication.",{"measure":26,"description":27,"timeFrame":28},"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",{"measure":30,"description":31,"timeFrame":28},"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.",null,{"allocation":34,"interventionModel":35,"interventionModelDescription":36,"primaryPurpose":37,"observationalModel":32,"timePerspective":32,"maskingInfo":38},"RANDOMIZED","PARALLEL","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.","TREATMENT",{"masking":39,"maskingDescription":40,"whoMasked":41},"SINGLE","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.",[42],"OUTCOMES_ASSESSOR","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.\n\nThe 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.\n\nThis 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.",[45,51],{"label":46,"type":47,"description":48,"interventionNames":49},"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.",[50],"Procedure: Primary Closure with HIEDI",{"label":52,"type":53,"description":54,"interventionNames":55},"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.",[56],"Procedure: Delayed Primary Closure with HIEDI",[58,62],{"type":59,"name":46,"description":60,"armGroupLabels":61,"otherNames":32},"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.",[46],{"type":59,"name":52,"description":63,"armGroupLabels":64,"otherNames":32},"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.",[52],[66],{"name":67,"affiliation":68,"role":69},"Dr. Yasser Abdurabo Obadiel, Associate Professor","Faculty of Medicine and Health Sciences, Sana'a University","STUDY_DIRECTOR",[71,76],{"name":72,"role":73,"phone":74,"phoneExt":32,"email":75},"Dr. Abdulla Salem Faraj, M.D.","CONTACT","+967770378499","a770378499@gmail.com",{"name":67,"role":73,"phone":74,"phoneExt":32,"email":77},"Yasser.Obadiel@su.edu.ye",[79,95,104],{"facility":80,"status":32,"city":81,"state":32,"zip":32,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"Al-Gumhori Teaching Hospital","Sanaa","Yemen","YE",{"type":85,"coordinates":86},"Point",[87,88],44.20646,15.35452,{"lat":88,"lon":87},[91,92,93],{"name":72,"role":73,"phone":74,"phoneExt":32,"email":75},{"name":67,"role":73,"phone":74,"phoneExt":32,"email":77},{"name":72,"role":94,"phone":32,"phoneExt":32,"email":32},"PRINCIPAL_INVESTIGATOR",{"facility":96,"status":32,"city":81,"state":32,"zip":32,"country":82,"countryCode":83,"cosmosGeoPoint":97,"geoPoint":99,"contacts":100},"Al-Kuwaint University Hospital",{"type":85,"coordinates":98},[87,88],{"lat":88,"lon":87},[101,102,103],{"name":72,"role":73,"phone":74,"phoneExt":32,"email":75},{"name":67,"role":73,"phone":74,"phoneExt":32,"email":77},{"name":72,"role":94,"phone":32,"phoneExt":32,"email":32},{"facility":105,"status":32,"city":81,"state":32,"zip":32,"country":82,"countryCode":83,"cosmosGeoPoint":106,"geoPoint":108,"contacts":109},"Al-Thawra Modern General Hospital",{"type":85,"coordinates":107},[87,88],{"lat":88,"lon":87},[110,111,112],{"name":72,"role":73,"phone":74,"phoneExt":32,"email":75},{"name":67,"role":73,"phone":74,"phoneExt":32,"email":77},{"name":72,"role":94,"phone":32,"phoneExt":32,"email":32},{"type":94,"investigatorFullName":114,"investigatorTitle":115,"investigatorAffiliation":5,"oldNameTitle":32,"oldOrganization":32},"Haitham Mohammed Jowah","Lecturer","100646757","primary-versus-delayed-wound-closure-in-complicated-appendectomy-the-hiedi-yemen-trial-100646757",false,"NCT07688109","Primary Versus Delayed Wound Closure in Complicated Appendectomy (The HIEDI-Yemen Trial)","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","HIEDI-Yemen","Inclusion Criteria:\n\n* Age 12 years and older\n* Intraoperative diagnosis of complicated appendicitis (perforation or gangrene)\n* Undergoing open appendectomy via McBurney or Rocky-Davis incision\n* Ability to provide written informed consent (patient or legal guardian for minors)\n* Availability for 30-day follow-up\n\nExclusion Criteria:\n\n* Generalized peritonitis requiring midline laparotomy\n* Immunocompromised status (e.g., chronic corticosteroid or immunosuppressive therapy, diagnosed HIV infection)\n* Poorly controlled diabetes mellitus (Hemoglobin A1c \\[HbA1c\\] greater than 8%)\n* Pregnancy\n* Concurrent malignancy\n* American Society of Anesthesiologists (ASA) physical status classification IV or V\n* Laparoscopic appendectomy","ALL","12 Years",{"count":127,"type":128},200,"ESTIMATED","INTERVENTIONAL",[131],"NA","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.\n\nThe main questions it aims to answer are:\n\n* 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?\n* 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?\n* What is the impact of each closure method on patient satisfaction and health-related quality of life?\n\nResearchers 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.\n\nParticipants will:\n\n* Undergo open appendectomy for intraoperatively confirmed complicated appendicitis (perforation or gangrene).\n* Receive standardized HIEDI wound decontamination (meticulous debridement and pulsatile irrigation with minimum 500 mL povidone-iodine 1:10 solution).\n* Be randomly allocated to either primary closure (all layers closed at surgery) or delayed primary closure (skin\u002Fsubcutaneous tissue left open and closed 3-5 days later).\n* Attend follow-up visits at days 7, 14, and 30 for wound assessment, infection surveillance, and outcome evaluation.",[134,135,136,137],"Appendicitis","Surgical Wound Infection","Postoperative Complications","Wound Healing",[139,140,141,142,143,144,145,82,146,147],"Complicated appendicitis","Primary wound closure","Delayed primary closure","Surgical Site Infection","HIEDI technique","Wound decontamination","Appendectomy","Randomized controlled trial","High-Efficiency Incision and Drainage with Irrigation","NOT_YET_RECRUITING","2026-07-02",{"date":151,"type":152},"2026-07-07","ACTUAL",{"date":154,"type":128},"2026-07-01",{"date":156,"type":128},"2026-11-30",{"name":5,"class":6},3]