Prophylactic subcutaneous drainage after gynecologic cancer surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, open-label trial compares prophylactic subcutaneous closed-suction drainage to standard closure without drainage in adult women undergoing midline laparotomy for gynecologic oncology. Eligible participants are assessed intraoperatively for subcutaneous tissue thickness of 2.5 cm or greater and then randomized to receive a drain or not. The primary outcome is wound complications within 30 days post-surgery, with standard surgical closure applied in both arms. The study is single-center, with masking not used due to the visible nature of the intervention, and informed consent obtained preoperatively.

Why it matters

Who can join: the full rules

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

Where it's running

• Başakşehir Çam and Sakura City Hospital
  Istanbul, Turkey (Türkiye) Recruiting

Study contacts

• Principal investigator: Mahmut Yassa, Md — Başakşehir Çam & Sakura City Hospital
• Study coordinator: MAHMUT yassa, MD
• Email: mahmut_yassa@hotmail.com
• Phone: +905396635484

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.