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 range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial compared not using a wound dressing at all versus doing routine dressing changes after gastrointestinal cancer surgery — based on what the results showed, which approach does my surgeon think would be better for my specific situation?
2Since this trial tracked wound complications like infections and pain for 30 days after surgery, what does my doctor think the findings mean for how my incision would be monitored and cared for if I have this type of surgery?
3The trial is now completed — has my surgical team seen or reviewed the results, and do they feel the evidence is strong enough to change how they currently manage wound care after gastrointestinal cancer operations?
4Given that wound infections are one of the things this trial was measuring, are there factors specific to my health — like diabetes, immune status, or the type of tumor I have — that might affect which wound care approach would be safest for me?
5Would skipping a wound dressing after my surgery affect how easily I could manage recovery at home, and is that something my care team would consider when deciding on my post-operative wound care plan?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of composite wound complications within 30 days after surgery
. 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).