Non-Dressing vs. Routine Dressing Change After Gastrointestinal Cancer Surgery

Fudan University1,138 enrolled

Overview

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: 1. Is omitting dressings noninferior to routine dressing changes in preventing a composite of wound complications requiring clinical intervention? 2. 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.

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: Participants were randomly assigned in a 1:1 ratio to either the non-dressing group or the routine dressing group. In the non-dressing group, the initial dressing was removed 48 hours postoperatively, with no further disinfection, cleansing, or wound coverage unless specific clinical indications arose (e.g., purulent discharge, extensive erythema). In the routine dressing group, patients received standardized dressing changes every 48 hours, consisting of disinfection with 10% povidone-iodine and application of a new sterile dressing, until suture removal at 7-14 days postoperatively. All wound complications were adjudicated by an independent, blinded Endpoint Committee using standardized photographic evidence. Follow-up and Outcomes: Follow-up assessments were conducted every other day before discharge and at postoperative days 14 and 30. The primary outcome was the composite incidence of postoperative wound complications requiring clinical intervention within 30 days after surgery (incisional SSI, fat liquefaction, hematoma, wound dehiscence, or delayed healing). Secondary outcomes included individual complication rates, pain scores measured by Visual Analog Scale (VAS, 0-10) on postoperative days 2, 4, and 6, and total dressing-related costs. Statistical Analysis: The primary analysis was performed on the intention-to-treat population. Non-inferiority was concluded if the upper bound of the two-sided 95% confidence interval for the risk difference (non-dressing minus dressing) was below the prespecified margin of +6%. The non-inferiority hypothesis was tested with a one-sided alpha of 0.025.

Interventions

Non-Dressing of Surgical WoundPROCEDURE

Participants received standard wound disinfection and initial sterile dressing immediately after surgery. At 48 hours postoperatively, the initial dressing was removed. Unless specific clinical indications arose (e.g., purulent discharge, extensive erythema), no further disinfection or wound coverage was performed. The incision remained exposed until suture removal at 7-14 days postoperatively. This intervention evaluates the noninferiority of omitting routine dressing changes in terms of wound complications, pain reduction, and cost savings.

Regular Dressing Change of Surgical WoundPROCEDURE

This intervention involves standard postoperative wound care. After surgery, wounds were disinfected and covered with dressings. Dressings were changed every 48 hours (with disinfection and reapplication) until suture removal (7-14 days postoperatively), following traditional wound management practices.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged between 18 and 75 years. 2. Having undergone elective gastrointestinal surgery for gastrointestinal cancer (histologically confirmed) within the past 24 hours. 3. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1. 4. Possessing sufficient cognitive ability to understand the study protocol and voluntarily signing a written informed consent form. Exclusion Criteria: 1. 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). 2. Concurrent active skin diseases that may affect wound healing (e.g., psoriasis, chronic eczema, atopic dermatitis) located at or near the surgical incision site. 3. History of major abdominal trauma or prior abdominal surgery resulting in abdominal wall deformity or extensive scarring that may affect incision healing or assessment. 4. 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. 5. Planned or ongoing receipt of any other anticancer treatments (chemotherapy, targeted therapy, biological therapy, radiotherapy) or long-term immunosuppressive therapy during the perioperative period. 6. 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).

Outcomes

Primary Outcomes

Incidence of composite wound complications 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.

Time frame: Within 30 days after surgery

Secondary Outcomes

Postoperative Pain Score

Pain intensity measured using the Visual Analog Scale (VAS), a 0-10 scale with higher scores indicating greater pain. Assessments are performed at rest by trained research staff.

Time frame: Postoperative days 2, 4, and 6

Total Dressing-Related Costs

Direct costs calculated from the hospital perspective using standardized fee schedules. Total cost per patient includes three components: (1) material costs (primary sterile dressing), (2) nursing procedure fees for each dressing change (classified as minor, intermediate, or major according to the National Catalog of Medical Service Prices), and (3) any additional treatment costs incurred due to management of wound complications.

Time frame: From the time of surgery up to 30 days post-surgery