Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy (SCDRAIN-GO)

Effect of Prophylactic Subcutaneous Drainage on Wound Complications in Patients With Thick Subcutaneous Tissue Undergoing Midline Laparotomy for Gynecologic Oncology Surgery: A Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Wound Complication; Gynecologic Cancers; Surgical Site Infection (SSI)
• Intervention / Treatment: Procedure: Prophylactic subcutaneous closed-suction drainage; Procedure: Standard closure without subcutaneous drainage

Detailed Description

Wound complications after gynecologic oncology surgery are clinically important because they may increase postoperative morbidity, delay recovery, prolong hospital stay, and postpone planned adjuvant treatment. Increased subcutaneous tissue thickness is a recognized surgical risk factor for wound-related problems after abdominal surgery. However, the benefit of routinely placing a prophylactic drain in the subcutaneous tissue remains uncertain, and practice varies among surgeons.

This study will evaluate a standardized approach to prophylactic subcutaneous drainage in participants undergoing gynecologic oncology surgery through a midline laparotomy. The study is designed as a single-center, prospective, randomized, open-label, parallel-group clinical trial. Because the intervention is a surgical procedure that is visible to the operating team and to postoperative care providers, masking will not be used.

Written informed consent will be obtained before surgery from potentially eligible participants. The final eligibility for randomization will be confirmed during surgery by measuring the subcutaneous tissue thickness with a sterile ruler at the thickest part of the incision. Participants who meet the intraoperative thickness requirement will be assigned to one of the study groups using a pre-generated randomization sequence and sequentially numbered, opaque, sealed envelopes.

The study compares two standard surgical approaches used in routine clinical practice: placement of a closed-suction drain in the subcutaneous tissue versus no subcutaneous drain. No investigational drug, biological product, or experimental medical device will be used. In both groups, subcutaneous tissue approximation will be standardized with interrupted 2/0 Vicryl sutures. In the drainage group, the subcutaneous drain will be managed according to a predefined removal criterion based on the 24-hour drainage volume, unless clinical circumstances require a different decision.

Postoperative care will otherwise follow the usual clinical practice of the gynecologic oncology surgery service. Wound-related findings and postoperative clinical data will be collected during hospitalization, at discharge, and during the postoperative follow-up period. Hospital records, outpatient assessments, readmission records, and telephone follow-up may be used to complete follow-up information when needed.

The primary analysis will follow the intention-to-treat principle, with participants analyzed according to their randomized group. A supportive per-protocol analysis will also be performed to assess the effect of protocol adherence. The main treatment effect will be expressed using absolute risk difference with 95% confidence intervals, with relative effect estimates reported as additional measures. The results are expected to clarify whether routine prophylactic subcutaneous drainage provides clinically meaningful benefit in patients with thick subcutaneous tissue undergoing gynecologic oncology midline laparotomy.

Prespecified exploratory analyses will examine the association between baseline and intraoperative variables (body mass index, diabetes mellitus, preoperative hemoglobin, preoperative serum albumin, operative duration, bowel intervention, and subcutaneous tissue thickness) and 30-day composite wound complication using multivariable logistic regression. These analyses are exploratory and are not registered as outcome measures.

• Study Type: Interventional
• Enrollment (Estimated): 334
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: MAHMUT yassa, MD; Phone Number: +905396635484; Email: mahmut_yassa@hotmail.com
• Study Contact Backup: Name: Bora Taşpınar, MD; Phone Number: +905053946331; Email: borataspinar@gmail.com

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye)
    • Recruiting
    • Başakşehir Çam and Sakura City Hospital
    • Contact: mahmut yassa; Phone Number: +905396635484; Email: mahmut_yassa@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Subcutaneous Drain; 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; 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.
Active Comparator: No Subcutaneous Drain; 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; Standardized subcutaneous tissue approximation and skin closure without placement of a prophylactic subcutaneous drain.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Surgical site infection within 30 postoperative days	Incidence of surgical site infection within 30 postoperative days, including superficial or deep incisional surgical site infection as clinically diagnosed and recorded during postoperative follow-up.	Up to 30 days after surgery
Wound dehiscence within 30 postoperative days	Incidence of wound dehiscence within 30 postoperative days, including superficial or deep wound separation documented during postoperative follow-up.	Up to 30 days after surgery
Clinically significant subcutaneous seroma within 30 postoperative days	Incidence of clinically significant subcutaneous seroma within 30 postoperative days. Clinically significant seroma is defined as a seroma requiring additional wound care beyond routine postoperative care, unscheduled clinical assessment, imaging, antibiotic treatment, aspiration, drainage, readmission, or surgical intervention.	Up to 30 days after surgery
Clinically significant subcutaneous hematoma within 30 postoperative days	Incidence of clinically significant subcutaneous hematoma within 30 postoperative days. Clinically significant hematoma is defined as a hematoma requiring additional wound care beyond routine postoperative care, unscheduled clinical assessment, imaging, antibiotic treatment, aspiration, drainage, readmission, or surgical intervention.	Up to 30 days after surgery
Wound-related intervention within 30 postoperative days	Incidence of wound-related intervention within 30 postoperative days. Wound-related intervention is defined as any wound-directed procedure performed because of a postoperative wound complication, including aspiration, drainage, re-suturing, surgical revision, or operative wound debridement, regardless of whether the procedure is performed in an inpatient or outpatient setting.	Up to 30 days after surgery
Wound-related readmission within 30 postoperative days	Incidence of hospital readmission within 30 postoperative days due to a wound-related complication.	Up to 30 days after surgery
Postoperative length of hospital stay	Length of postoperative hospital stay, defined as the number of days from surgery to hospital discharge.	From the date of surgery to hospital discharge, assessed up to 30 days after surgery
Subcutaneous tissue thickness in participants with and without 30-day composite wound complication	Subcutaneous tissue thickness, measured in centimeters intraoperatively with a sterile ruler at the thickest part of the midline incision, reported separately for participants with and without composite wound complication within 30 postoperative days.	Up to 30 days after surgery

Collaborators and Investigators

• Sponsor: Mahmut Yassa
• Investigators: Principal Investigator: MAHMUT YASSA, MD, Başakşehir Çam & Sakura City Hospital; Study Director: Bora Taşpınar, MD, Başakşehir Çam & Sakura City Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): March 1, 2028

Study Registration Dates

• First Submitted: July 16, 2026
• First Submitted That Met QC Criteria: July 29, 2026
• First Posted (Actual): July 30, 2026

Study Record Updates

• Last Update Posted (Actual): July 30, 2026
• Last Update Submitted That Met QC Criteria: July 29, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: randomized controlled trial; surgical site infection; wound complication; gynecologic oncology; midline laparotomy; subcutaneous drain; subcutaneous tissue thickness
• Additional Relevant MeSH Terms: Postoperative Complications; Pathologic Processes; Infections; Wound Infection; Pathological Conditions, Signs and Symptoms; Surgical Wound Infection
• Other Study ID Numbers: SCDRAIN-GO-RCT-2026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: De-identified individual participant data underlying the published results, together with a data dictionary, will be made available upon reasonable request to the corresponding investigator. Data will be shared only after publication of the primary study results and subject to institutional approval, a scientifically sound research proposal, and execution of a data use agreement. Additional data may be considered on a case-by-case basis at the discretion of the principal investigator.
• IPD Sharing Time Frame: Beginning 6 months after publication of the primary study results and ending 3 years after publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No