NCT06263205

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

A Randomized, Open-Label, Multicenter, Non-Inferiority Clinical Trial Comparing No Wound Dressing Change Versus Routine Wound Dressing Change After Gastrointestinal Surgery

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,138 (actual)
• Sponsor: Fudan University · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Gastrointestinal Tumors
• Surgical Wound Infection
• Pain, Postoperative

Interventions

Type	Name	Description
PROCEDURE	Non-Dressing of Surgical Wound	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.
PROCEDURE	Regular Dressing Change of Surgical Wound	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.

Timeline

• Start date: 2024-04-01
• Primary completion: 2025-07-30
• Completion: 2025-07-30
• First posted: 2024-02-16
• Last updated: 2026-03-03

Locations

4 sites across 1 country: China