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 range18 Years – 65 Years
SexALL
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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…