Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy

NCT07735962 | Recruiting

• 1 other identifier: SCDRAIN-GO-RCT-2026
• Study Type: interventional
• Target: 334
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

subcutaneous drain; gynecologic oncology; midline laparotomy; wound complication; surgical site infection; subcutaneous tissue thickness; randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• Composite wound complication within 30 postoperative days

  The primary outcome is the incidence of composite wound complication within 30 postoperative days. Composite wound complication is defined as the occurrence of at least one of the following: surgical site infection, wound dehiscence, clinically significant subcutaneous seroma, clinically significant subcutaneous hematoma, or wound-related intervention. Clinically significant subcutaneous seroma or hematoma is defined as a seroma or hematoma requiring any additional wound care beyond routine postoperative care, unscheduled clinical assessment, imaging, antibiotic treatment, aspiration, drainage, readmission, or surgical intervention. Wound-related intervention is defined as any wound-directed procedure (aspiration, drainage, re-suturing, surgical revision, or operative wound debridement) performed because of a postoperative wound complication, in either an inpatient or outpatient setting.

  Up to 30 days after surgery

Secondary Outcomes (8)

• Surgical site infection within 30 postoperative days

  Up to 30 days after surgery

• Wound dehiscence within 30 postoperative days

  Up to 30 days after surgery

• Clinically significant subcutaneous seroma within 30 postoperative days

  Up to 30 days after surgery

• Clinically significant subcutaneous hematoma within 30 postoperative days

  Up to 30 days after surgery

• Wound-related intervention within 30 postoperative days

  Up to 30 days after surgery

Study Arms (2)

Subcutaneous Drain

EXPERIMENTAL

Participants allocated to this arm will receive prophylactic closed-suction subcutaneous drainage after midline laparotomy and before skin closure. Subcutaneous tissue approximation will be performed with interrupted 2/0 Vicryl sutures. The drain will be removed when the 24-hour drainage volume is less than 30 mL, unless earlier or later removal is clinically indicated.

Procedure: Prophylactic subcutaneous closed-suction drainage

No Subcutaneous Drain

ACTIVE COMPARATOR

Participants allocated to this arm will undergo standard surgical closure without prophylactic subcutaneous drainage. Subcutaneous tissue approximation will be performed with interrupted 2/0 Vicryl sutures.

Procedure: Standard closure without subcutaneous drainage

Interventions

Standard closure without subcutaneous drainage PROCEDURE

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

No Subcutaneous Drain

Prophylactic subcutaneous closed-suction drainage PROCEDURE

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.

Subcutaneous Drain

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• Mahmut Yassa: lead

Study Sites (1)

Başakşehir Çam and Sakura City Hospital

Istanbul, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• MAHMUT YASSA, MD

  Başakşehir Çam & Sakura City Hospital

  PRINCIPAL INVESTIGATOR

• Bora Taşpınar, MD

  Başakşehir Çam & Sakura City Hospital

  STUDY DIRECTOR

Central Study Contacts

MAHMUT yassa, MD

CONTACT

+905396635484; mahmut_yassa@hotmail.com

Bora Taşpınar, MD

CONTACT

+905053946331; borataspinar@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking will be used. The intervention is a surgical procedure, and the presence or absence of a subcutaneous drain is visible to the surgical team, postoperative care providers, and participants.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Gynecologic Oncology Specialist

Model Details: Participants who provide written informed consent before surgery will undergo intraoperative measurement of subcutaneous tissue thickness. Participants with subcutaneous tissue thickness of 2.5 cm or greater will be randomized in a 1:1 ratio to one of two parallel groups: prophylactic subcutaneous drainage or no subcutaneous drainage. Randomization will be performed using a pre-generated block randomization sequence with sequentially numbered, opaque, sealed envelopes.

Study Record Dates

• First Submitted: July 16, 2026
• First Posted: July 30, 2026
• Study Start: July 20, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: July 30, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 6 months after publication of the primary study results and ending 3 years after publication.
• Access Criteria: Access will be considered for qualified researchers conducting scientifically sound research. Requests must include a research proposal and, where appropriate, a statistical analysis plan. All requests will be reviewed by the principal investigator and approved according to institutional policies. Approved researchers will be required to sign a data use agreement before receiving de-identified data.

Locations

TU (1)