Status:
COMPLETED
Clinical Study on Veloderm for the Treatment of Split-thickness Skin Graft Donor Sites
Lead Sponsor:
Lee's Pharmaceutical Limited
Collaborating Sponsors:
Ruijin Hospital
Guangzhou First People's Hospital
Conditions:
Split-thickness Skin Graft Donor Sites
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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 resu...
Detailed Description
The rational oxygen permeability of Veloderm dressing also provides a good environment for wound healing. Therefore, it can be as a temporary skin substitute in the case of missing epidermis to play a...
Eligibility Criteria
Inclusion
- 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
- 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 with immunosuppressants, antineoplastic drugs and corticosteroids for a long time
- Subject who has not signed the informed consent form.
Key Trial Info
Start Date :
June 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2010
Estimated Enrollment :
96 Patients enrolled
Trial Details
Trial ID
NCT01512017
Start Date
June 1 2008
End Date
May 1 2010
Last Update
January 25 2012
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