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Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy
Sponsor: Mahmut Yassa
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
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.
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)