At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Open-Label, Multicenter, Non-Inferiority Clinical Trial Comparing No Wound Dressing Change Versus Routine Wound Dressing Change After Gastrointestinal Surgery
In Brief
A clinical study evaluating Non-Dressing of Surgical Wound and Regular Dressing Change of Surgical Wound for Gastrointestinal Tumors and 2 related conditions. Completed, enrolled 1,138 participants across 4 sites.
Signals
Detailed 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.
Study Details
Timeline
Arms & Interventions
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.
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.
Interventions
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.
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.