Ireland
--:--IST
Recruiting Not applicable

Vacuum Sealing Drainage (VSD) in Promoting Wound Healing and Reducing Complications in Post-Infected Obstetric and Gynecological Surgical Sites

NCT07525674 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2026-04-20
Last updated
2026-07-21

Condition(s) studied

Wound Heal

Investigational drug(s) / intervention(s)

Conventional Wound Care GroupVacuum Sealing Drainage (VSD) Group

Conventional Wound Care Group: o 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: After 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.

Study 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

Sex
FEMALE
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Time to complete wound healing — weekly follow up for one month after procedure
    Defined as complete epithelialization of the wound, measured in days

Trial sites (1)

FacilityCityRegionStatus
Minia advanced laparoscopy unit Minya Egypt Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07525674 on ClinicalTrials.gov ↗ ← All trials in Egypt