Evaluation of Subcutaneous Drain Use to Prevent Wound Problems After Gynecologic Cancer Surgery via Midline Laparotomy

What this Trial Is About

Researchers are investigating whether placing a small drain under the skin can help reduce wound complications in adult women undergoing gynecologic oncology surgery through a midline laparotomy, especially for those with a thick layer of tissue under the skin. The study focuses on comparing wound problems within 30 days after surgery between women who have the drain placed and those who do not. This is a single-center, randomized clinical trial evaluating standard surgical practices with no experimental drugs or devices. Participants will be randomly assigned during surgery based on a tissue thickness measurement of 2.5 cm or more to either receive a closed-suction subcutaneous drain before skin closure or have standard closure without a drain. In both groups, the tissue under the skin will be closed with stitches. The drain will be removed when drainage falls below a specified level unless clinical reasons dictate otherwise. The study compares these two approaches to understand if the drain helps prevent wound-related problems. Participants will be followed for 30 days after surgery to monitor for wound issues such as infection, wound separation, fluid or blood collection, or the need for additional wound care or procedures. Data will be collected from hospital records, outpatient visits, readmissions, and phone follow-ups. The primary outcome is a composite measure of wound complications within 30 days, with additional measures including infections, seromas, hematomas, readmissions, and hospital stay length. This monitoring will help clarify the benefit of routine subcutaneous drainage in this patient group.

Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy