Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy
Recruiting now · Not applicable
Conditions studied: Wound Complication, Surgical Site Infection (SSI), Gynecologic Cancers
In brief
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.
Key facts
- Study ID
- NCT07735962
- Run by
- Mahmut Yassa
- People needed
- 334
- Starts
- 2026-07-20
- Expected to finish
- 2028-03-01
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- Emergency surgery
- Active infection before surgery
- Severe immunosuppression
- Refusal to provide written informed consent
Where it is running
- Başakşehir Çam and Sakura City Hospital — Istanbul, Turkey (Türkiye) (enrolling)
Full record on ClinicalTrials.gov
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