[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646757":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":29,"centralContacts":34,"locations":42,"responsibleParty":77,"collaborators":25,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":82,"sex":88,"minAge":89,"maxAge":25,"enrollmentInfo":90,"targetDuration":25,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":102,"overallStatus":112,"whyStopped":25,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":119,"leadSponsor":121,"locationsCount":122},{"fullName":5,"class":6},"Sana'a University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"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.",[13],"Procedure: Primary Closure with HIEDI",{"label":15,"type":16,"description":17,"interventionNames":18},"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.",[19],"Procedure: Delayed Primary Closure with HIEDI",[21,26],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"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.",[9],null,{"type":22,"name":15,"description":27,"armGroupLabels":28,"otherNames":25},"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.",[15],[30],{"name":31,"affiliation":32,"role":33},"Dr. Yasser Abdurabo Obadiel, Associate Professor","Faculty of Medicine and Health Sciences, Sana'a University","STUDY_DIRECTOR",[35,40],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},"Dr. Abdulla Salem Faraj, M.D.","CONTACT","+967770378499","a770378499@gmail.com",{"name":31,"role":37,"phone":38,"phoneExt":25,"email":41},"Yasser.Obadiel@su.edu.ye",[43,59,68],{"facility":44,"status":25,"city":45,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Al-Gumhori Teaching Hospital","Sanaa","Yemen","YE",{"type":49,"coordinates":50},"Point",[51,52],44.20646,15.35452,{"lat":52,"lon":51},[55,56,57],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":31,"role":37,"phone":38,"phoneExt":25,"email":41},{"name":36,"role":58,"phone":25,"phoneExt":25,"email":25},"PRINCIPAL_INVESTIGATOR",{"facility":60,"status":25,"city":45,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Al-Kuwaint University Hospital",{"type":49,"coordinates":62},[51,52],{"lat":52,"lon":51},[65,66,67],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":31,"role":37,"phone":38,"phoneExt":25,"email":41},{"name":36,"role":58,"phone":25,"phoneExt":25,"email":25},{"facility":69,"status":25,"city":45,"state":25,"zip":25,"country":46,"countryCode":47,"cosmosGeoPoint":70,"geoPoint":72,"contacts":73},"Al-Thawra Modern General Hospital",{"type":49,"coordinates":71},[51,52],{"lat":52,"lon":51},[74,75,76],{"name":36,"role":37,"phone":38,"phoneExt":25,"email":39},{"name":31,"role":37,"phone":38,"phoneExt":25,"email":41},{"name":36,"role":58,"phone":25,"phoneExt":25,"email":25},{"type":58,"investigatorFullName":78,"investigatorTitle":79,"investigatorAffiliation":5,"oldNameTitle":25,"oldOrganization":25},"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":91,"type":92},200,"ESTIMATED","INTERVENTIONAL",[95],"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.",[98,99,100,101],"Appendicitis","Surgical Wound Infection","Postoperative Complications","Wound Healing",[103,104,105,106,107,108,109,46,110,111],"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":115,"type":116},"2026-07-07","ACTUAL",{"date":118,"type":92},"2026-07-01",{"date":120,"type":92},"2026-11-30",{"name":5,"class":6},3]