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Recruiting
NCT07525674
Vacuum Sealing Drainage (VSD) in Promoting Wound Healing and Reducing Complications in Post-Infected Obstetric and Gynecological Surgical Sites
Conditions: Wound Heal
Sex: Female
Ages: 18 Years – 70 Years
Healthy volunteers: No
Phase: NA
Enrollment: 60
Sponsor: Minia University
Location: Minia advanced laparoscopy unit Minya
Summary
This study aims to evaluate the efficacy of VSD in promoting wound healing and reducing complications, such as re-infection, prolonged hospitalization, and need for further surgical interventions, in obstetric and gynecological patients who have developed surgical site infections following their primary procedures. The investigators hypothesize that VSD will lead to faster wound healing, fewer complications, and improved patient outcomes compared to conventional wound care in this specific patient population.
Eligibility Criteria
Inclusion Criteria:
* Diagnosis of a surgical site infection (SSI) following an obstetric or gynecological surgical procedure (e.g., Cesarean section, hysterectomy, myomectomy, salpingo-oophorectomy).
* Wound classification as superficial incisional SSI, deep incisional SSI, or organ/space SSI (if accessible for VSD application).
* Willingness and ability to provide informed consent.
* Wound requiring secondary intention healing or delayed primary closure after debridement
Exclusion Criteria:
* Patients with necrotic tissue.
* Presence of exposed blood vessels, organs, or anastomotic sites where VSD is contraindicated.
* Untreated coagulopathy or active bleeding diathesis.
* Allergy to VSD components or dressing materials.
* Patients with significant immunosuppression (e.g., uncontrolled HIV, organ transplant recipients on high-dose immunosuppressants).
* Patients with malignant wounds.
* Patients who decline participation.
* Patients requiring immediate primary wound closure without debridement.
* Patients with a known history of severe psychiatric illness affecting compliance.
Source: ClinicalTrials.gov (NCT07525674). StuddyBuddy aggregates publicly available trial information.