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RECRUITING
NCT07735962
NA

Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy

Sponsor: Mahmut Yassa

View on ClinicalTrials.gov

Summary

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.

Official title: Effect of Prophylactic Subcutaneous Drainage on Wound Complications in Patients With Thick Subcutaneous Tissue Undergoing Midline Laparotomy for Gynecologic Oncology Surgery: A Randomized Controlled Trial

Key Details

Gender

FEMALE

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

334

Start Date

2026-07-20

Completion Date

2028-03-01

Last Updated

2026-07-30

Healthy Volunteers

No

Interventions

PROCEDURE

Prophylactic subcutaneous closed-suction drainage

Placement of a closed-suction drain in the subcutaneous tissue before skin closure in patients with intraoperative subcutaneous tissue thickness of 2.5 cm or greater.

PROCEDURE

Standard closure without subcutaneous drainage

Standardized subcutaneous tissue approximation and skin closure without placement of a prophylactic subcutaneous drain.

Locations (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)