Идёт набор NCT07735962

Prophylactic Subcutaneous Drainage After Gynecologic Oncology Midline Laparotomy

Без фазы С лечением Wound Complication Surgical Site Infection (SSI) Gynecologic Cancers

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Prophylactic subcutaneous closed-suction drainage, Standard closure without subcutaneous drainage.
Кому может быть актуально: Состояния в реестре: Wound Complication, Surgical Site Infection (SSI), Gynecologic Cancers. Базовые параметры: от 18 лет · Женщины.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Turkey (Türkiye)
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

Composite wound complication within 30 postoperative days [Срок оценки: Up to 30 days after surgery]

Вторичные конечные точки (8)

Surgical site infection within 30 postoperative days [Срок оценки: Up to 30 days after surgery]
Wound dehiscence within 30 postoperative days [Срок оценки: Up to 30 days after surgery]
Clinically significant subcutaneous seroma within 30 postoperative days [Срок оценки: Up to 30 days after surgery]
Clinically significant subcutaneous hematoma within 30 postoperative days [Срок оценки: Up to 30 days after surgery]
Wound-related intervention within 30 postoperative days [Срок оценки: Up to 30 days after surgery]
Wound-related readmission within 30 postoperative days [Срок оценки: Up to 30 days after surgery]
Postoperative length of hospital stay [Срок оценки: 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 [Срок оценки: Up to 30 days after surgery]

Критерии участия

Критерии включения

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