Clinical trial · Interventional
Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancers | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Surgical Site Infection (SSI) | — | UNRESOLVED | — |
| Wound Complication | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prophylactic subcutaneous closed-suction drainage | Procedure | — | UNRESOLVED |
| Standard closure without subcutaneous drainage | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Subcutaneous Drain
- description
- 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.
- interventionNames
- Procedure: Prophylactic subcutaneous closed-suction drainage
- type
- ACTIVE_COMPARATOR
- label
- No Subcutaneous Drain
- description
- 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.
- interventionNames
- Procedure: Standard closure without subcutaneous drainage
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available