Clinical Study on Veloderm for the Treatment of Split-thickness Skin Graft Donor Sites (NCT01512017) | Clinical Trial Compass
CompletedPhase 3
Clinical Study on Veloderm for the Treatment of Split-thickness Skin Graft Donor Sites
96 participantsStarted 2008-06
Plain-language summary
This study is a multi-center, randomized, open and paralleled positive control study for evaluating the safety and efficacy of Veloderm in treatment of split-thickness skin graft donor sites. The result implies that Veloerm can do it better than Vaseline gauze in accelerating and promoting wound healing of skin graft donor sites. The present study have indicated that high permeability of Veloderm dressing to oxygen and water vapor.
Who can participate
Age range
18 Years – 65 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 18-65 years
* Male or female patients
* Skin lesions or losses by burns, plastic surgery, sores, abrasions, donor graft areas and after debridement of chronic wounds
* The area of skin loss or burn surface is less than 50% of total area of body surface
* Subject undergoing first skin harvest 0.25-0.35mm and donor site having a surface area\>100cm2
* Subject who is willing to participate in the trial and to sign the informed consent form.
Exclusion Criteria:
* Area of skin loss or burn surface is larger than 50% of total area of body surface
* Electrical burns or chemical burns
* Burns complicated by combined injury
* Test wound needs drugs that may affect wound healing
* Subject who has a known hypersensitivity to hemycellulose
* Contraindication to the use of semi occlusive dressing
* Pregnant or lactating subject
* Any severe disease which in the Investigator's judgement might interfere with study evaluations or threaten patient's safety
* Subject who has chronic renal disease or renal inadequacy, or serum creatinine is more than twice the upper limit of normal
* Subject who has a definite liver disease, TBil or AST, ALT is more than twice the upper limit of normal
* Subject with active hemorrhoea or shock or visceral injury; Subject who has participated in this clinical study or other clinical studies within 3 months
* Subject with mental impairment limiting the ability to comply with study requirements; Subject undergone chronic treatment wit…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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.