Overview
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.
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.
Eligibility
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
