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

M

Minia University

Status

Not yet enrolling

Conditions

Wound Heal

Treatments

Biological: Vacuum Sealing Drainage (VSD) Group
Biological: Conventional Wound Care Group

Study type

Interventional

Funder types

Other

Identifiers

NCT07525674
1705-9-25

Details and patient eligibility

About

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.

Enrollment

30 estimated patients

Sex

Female

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

30 participants in 2 patient groups

Conventional Wound Care Group
Active Comparator group
Treatment:
Biological: Conventional Wound Care Group
Vacuum Sealing Drainage (VSD) Group
Experimental group
Treatment:
Biological: Vacuum Sealing Drainage (VSD) Group

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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