Join us at Health Research Day — June 6th at Canton Waterfront Park, Baltimore!   Learn More →
← Back to all trials
Recruiting NCT07735962

Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy

Conditions: Wound Complication, Surgical Site Infection (SSI), Gynecologic Cancers

Sex: Female
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 334
Sponsor: Mahmut Yassa

Location: Başakşehir Çam and Sakura City Hospital Istanbul

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.

Eligibility Criteria

Inclusion Criteria: * 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 Exclusion Criteria: * Emergency surgery * Active infection before surgery * Severe immunosuppression * Refusal to provide written informed consent

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07735962). StuddyBuddy aggregates publicly available trial information.