About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Parallel
Treatments tested in this trial
Conventional Wound Care Group
Biological/Vaccineo Wounds will be managed with daily or twice-daily dressing changes using saline-moistened gauze, antiseptic solutions, and sterile dry dressings, as per standard hospital protocols for infected wounds
Vacuum Sealing Drainage (VSD) Group
Biological/VaccineAfter initial debridement, a VSD system will be applied to the wound bed. The wound will be sealed with an adhesive drape, and connected to a negative pressure unit.
Treatment groups
Trial outcomes
Primary outcomes
Time to complete wound healing
Defined as complete epithelialization of the wound, measured in days
Sponsors and contacts
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