Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMahmut Yassa

About this trial

The goal of this clinical trial is to learn whether placing a small drain under the skin can help prevent wound problems after gynecologic oncology surgery in adult women with a thick layer of tissue under the skin.

The main question it aims to answer is:

Does a small drain placed under the skin lower the number of wound complications within 30 days after surgery?

Researchers will compare two groups:

Participants in one group will have a small closed-suction drain placed under the skin before the skin is closed.

Participants in the other group will not have a drain placed under the skin.

All participants will have midline abdominal surgery. During surgery, the surgeon will measure the thickness of the tissue under the skin. Participants with a thickness of 2.5 cm or more will be randomly assigned to one of the two groups.

In both groups, the tissue under the skin will be closed in a standard way using separate 2/0 Vicryl stitches. Participants in the drain group will have the drain removed when the amount of fluid collected in 24 hours is less than 30 mL, unless the surgeon decides that earlier or later removal is needed.

Participants will be followed for 30 days after surgery to check for wound problems such as infection, wound separation, fluid collection, blood collection, or the need for extra wound care or another procedure.

Eligibility criteria

Qualifiers

Female participants aged 18 years or older

Undergoing midline laparotomy for gynecologic oncology surgery

Intraoperative subcutaneous tissue thickness of 2.5 cm or greater, measured at the thickest part of the incision

Able and willing to provide written informed consent before surgery

Disqualifiers

Emergency surgery

Active infection before surgery

Severe immunosuppression

Refusal to provide written informed consent

Trial design

Treatments tested in this trial

  • Prophylactic subcutaneous closed-suction drainage
  • Standard closure without subcutaneous drainage

Treatment groups

334 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Mahmut Yassa

Lead sponsor

Başakşehir Çam & Sakura City Hospital

Sponsor institution