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

NCT07525674 | Not Yet Recruiting

• 1 other identifier: 1705-9-25
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Wound Heal

Outcome Measures

Primary Outcomes (1)

• Time to complete wound healing

  Defined as complete epithelialization of the wound, measured in days

  weekly follow up for one month after procedure

Study Arms (2)

Conventional Wound Care Group

ACTIVE COMPARATOR

Biological: Conventional Wound Care Group

Vacuum Sealing Drainage (VSD) Group

EXPERIMENTAL

Biological: Vacuum Sealing Drainage (VSD) Group

Interventions

Conventional Wound Care Group BIOLOGICAL

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

Conventional Wound Care Group

Vacuum Sealing Drainage (VSD) Group BIOLOGICAL

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.

Vacuum Sealing Drainage (VSD) Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Minia University: lead

MeSH Terms

Interventions

Population Groups

Intervention Hierarchy (Ancestors)

Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Obstetrics and Gynecology

Study Record Dates

• First Submitted: April 6, 2026
• First Posted: April 13, 2026
• Study Start: April 20, 2026
• Primary Completion (Estimated): January 20, 2027
• Study Completion (Estimated): April 20, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04