Vacuum Sealing Drainage (VSD) in Promoting Wound Healing and Reducing Complications in Post-Infected Obstetric and Gynecological Surgical Sites
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Conventional Wound Care Group, Vacuum Sealing Drainage (VSD) Group.
- Who it may be relevant to
- Registry conditions: Wound Heal. Basic parameters: 18 years — 70 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Biological 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 - Biological 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.
Primary outcome measures
- Time to complete wound healing [Time frame: weekly follow up for one month after procedure]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Minia advanced laparoscopy unit — Minya
Identifiers
NCT: NCT07525674 · 1705-9-25