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
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 334
- 试验地点
- 1
- 主要终点
- Composite wound complication within 30 postoperative days
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Emergency surgery
- •Active infection before surgery
- •Severe immunosuppression
- •Refusal to provide written informed consent
结局指标
主要结局
Composite wound complication within 30 postoperative days
时间窗: Up to 30 days after surgery
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.
次要结局
- 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)
- Wound-related readmission within 30 postoperative days(Up to 30 days after surgery)
- Postoperative length of hospital stay(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(Up to 30 days after surgery)
研究者
Mahmut Yassa
Gynecologic Oncology Specialist
Başakşehir Çam & Sakura City Hospital