A Randomized, Open-Label, Multicenter, Non-Inferiority Clinical Trial Comparing No Wound Dressing Change Versus Routine Wound Dressing Change After Gastrointestinal Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,138
- 试验地点
- 4
- 主要终点
- Incidence of composite wound complications within 30 days after surgery
研究概览
简要总结
The goal of this randomized non-inferiority trial is to evaluate whether omitting postoperative wound dressings is noninferior to routine dressing changes in patients undergoing gastrointestinal cancer surgery. The main questions it aims to answer are:
- Is omitting dressings noninferior to routine dressing changes in preventing a composite of wound complications requiring clinical intervention?
- Can omitting dressings reduce postoperative pain and eliminate dressing-related costs?
Participants diagnosed with gastrointestinal tumors undergoing elective surgery will be randomly assigned to either the non-dressing group or the routine dressing group. The non-dressing group will have their initial dressing removed at 48 hours postoperatively, with no further coverage or disinfection unless clinically indicated. The dressing group will receive standardized dressing changes every 48 hours until suture removal at 7-14 days. Researchers will compare the two groups regarding the rate of wound complications, pain scores, and total dressing-related costs.
This study aims to provide evidence-based recommendations for minimalist postoperative wound care, potentially improving patient comfort and reducing unnecessary medical expenses.
详细描述
Research Objectives and Design:
This study is a prospective, multicenter, randomized, open-label, parallel-group, non-inferiority trial. The primary objective is to demonstrate that omitting routine dressing changes is noninferior to standard care for preventing a composite of wound complications within 30 days after gastrointestinal cancer surgery. Secondary objectives are to compare postoperative pain scores and total dressing-related costs between the two strategies.
Inclusion Criteria and Sample Size:
A total of 1138 patients aged 18 to 75 years who underwent elective gastrointestinal surgery for histologically confirmed malignancies were enrolled and randomized. Key inclusion criteria included an ECOG Performance Status of 0 or 1. Key exclusion criteria included active skin disorders at the incision site, uncontrolled comorbidities, prior abdominal radiotherapy, recent immunosuppressive therapy, or inability to complete follow-up, as detailed in the protocol.
Study Methodology:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants, care providers, and investigators were not masked to group assignment due to the visible nature of the intervention (presence or absence of dressing). The outcomes assessor (Endpoint Adjudication Committee) and study statisticians were masked throughout the trial using standardized photographic evidence and redacted clinical data.
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 18 and 75 years.
- •Having undergone elective gastrointestinal surgery for gastrointestinal cancer (histologically confirmed) within the past 24 hours.
- •Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or
- •Possessing sufficient cognitive ability to understand the study protocol and voluntarily signing a written informed consent form.
排除标准
- •Presence of significant barriers to completing postoperative follow-up (e.g., severe sensory/cognitive impairment, inability to adhere to follow-up plan, lack of reliable contact methods, residence >6 hours from study center).
- •Concurrent active skin diseases that may affect wound healing (e.g., psoriasis, chronic eczema, atopic dermatitis) located at or near the surgical incision site.
- •History of major abdominal trauma or prior abdominal surgery resulting in abdominal wall deformity or extensive scarring that may affect incision healing or assessment.
- •Current diagnosis of any other uncontrolled severe comorbid conditions (e.g., uncontrolled other malignant tumors, acute or persistent chronic infections) that may pose additional risks or confound study outcomes.
- •Planned or ongoing receipt of any other anticancer treatments (chemotherapy, targeted therapy, biological therapy, radiotherapy) or long-term immunosuppressive therapy during the perioperative period.
- •Current long-term or high-dose use of systemic corticosteroids or any other medications that may significantly affect wound healing (topical/inhaled/low-dose steroids allowed if assessed by investigator).
研究组 & 干预措施
Dressing Group
Participants in this group received standard postoperative care. Their surgical wounds were covered with dressings immediately after surgery, and these dressings were changed every 48 hours (including disinfection and reapplication of dressing) until suture removal at 7-14 days postoperatively. This group serves as the comparator for assessing the non-dressing approach.
干预措施: Regular Dressing Change of Surgical Wound (Procedure)
Non-Dressing Group
Participants in this group received standard wound disinfection and initial sterile dressing immediately after surgery. At 48 hours postoperatively, the initial dressing was removed. No further disinfection, cleansing, or wound coverage was performed unless specific clinical indications arose. The incision remained exposed until suture removal at 7-14 days postoperatively. This arm evaluates whether omitting routine dressing changes is noninferior to standard care in preventing wound complications.
干预措施: Non-Dressing of Surgical Wound (Procedure)
结局指标
主要结局
Incidence of composite wound complications within 30 days after surgery
时间窗: Within 30 days after surgery
This is a composite endpoint including surgical site infection, wound dehiscence, hematoma/seroma requiring intervention, fat liquefaction, and delayed wound healing, each of which necessitated additional medical intervention. The non-inferiority of the "no dressing change" strategy versus the "routine dressing change" strategy will be tested using the Farrington-Manning test. The pre-specified non-inferiority margin (Δ) is 6%. Non-inferiority will be established if the upper limit of the two-sided 95% confidence interval for the difference in incidence rates (no dressing change minus routine dressing change) is below 6%. Time Frame: Up to 30 days after surgery.
次要结局
- Medical Costs Associated with Wound Care(From the time of surgery up to 30 days post-surgery)
- Postoperative Pain Score(Postoperative days 2, 4, and 6)
- Total Dressing-Related Costs(From the time of surgery up to 30 days post-surgery)