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

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

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07525674
Enrollment
60
Registered
2026-04-13
Start date
2026-04-20
Completion date
2027-04-20
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Heal

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.

Interventions

BIOLOGICALConventional 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

BIOLOGICALVacuum 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.

Sponsors

Minia University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 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.

Design outcomes

Primary

MeasureTime frameDescription
Time to complete wound healingweekly follow up for one month after procedureDefined as complete epithelialization of the wound, measured in days

Countries

Egypt

Contacts

CONTACTMohamed abdel ghfar
mohamedeleboany@gmail.com+20 10 61624335

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026