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NCT Number: NCT07525674

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

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.

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Key information

Conditions

Wound Heal

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Minia advanced laparoscopy unit

Minya, Egypt

Location status: Recruiting

Location contact

Mohamed abdelghfar, Lecturer

CONTACT

+20 10 61624335

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Time to complete wound healing

    Time frame: weekly follow up for one month after procedure

    Defined as complete epithelialization of the wound, measured in days

Study contacts

Contact information is provided by the study sponsor or research team.

Mohamed abdel ghfar

CONTACT

[email protected]

+20 10 61624335

Sponsors and collaborators

Lead sponsor

Minia University

Other

Registry information

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Apr 13, 2026
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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