Non-Dressing vs. Routine Dressing Change After Gastrointestinal Cancer Surgery (NCT06263205) | Clinical Trial Compass
CompletedNot Applicable
Non-Dressing vs. Routine Dressing Change After Gastrointestinal Cancer Surgery
China1,138 participantsStarted 2024-04-01
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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 1.
✓. Possessing sufficient cognitive ability to understand the study protocol and voluntarily signing a written informed consent form.
Exclusion criteria
✕. 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.
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What they're measuring
1
Incidence of composite wound complications within 30 days after surgery
. 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).