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Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy

NCT07735962 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 334

Last updated 2026-07-30

No results posted yet for this study

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.

Conditions

  • Wound Complication
  • Surgical Site Infection (SSI)
  • Gynecologic Cancers

Interventions

PROCEDURE

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.

PROCEDURE

Standard closure without subcutaneous drainage

Standardized subcutaneous tissue approximation and skin closure without placement of a prophylactic subcutaneous drain.

Sponsors & Collaborators

  • Mahmut Yassa

    lead OTHER_GOV

Principal Investigators

  • MAHMUT YASSA, MD · Başakşehir Çam & Sakura City Hospital

  • Bora Taşpınar, MD · Başakşehir Çam & Sakura City Hospital

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-20
Primary Completion
2028-01-01
Completion
2028-03-01

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07735962 on ClinicalTrials.gov