Clinical Study on Veloderm for the Treatment of Split-thickness Skin Graft Donor Sites
This study has been completed.
Lee's Pharmaceutical Limited
First Posted: January 19, 2012
Last Update Posted: January 25, 2012
Guangzhou First People's Hospital
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited
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.
|Split-thickness Skin Graft Donor Sites||Device: Crystalline cellulose simple occlusive dressing Device: Vaseline||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
|Official Title:||A Clinical Study to Evaluate the Safety and Efficacy on Veloderm (a Crystalline Cellulose Simple Occlusive Dressing) for the Split-thickness Skin Graft Donor Sites in Burn and Plastic Surgery|
Resource links provided by NLM:
Further study details as provided by Lee's Pharmaceutical Limited:
Primary Outcome Measures:
- Response Criteria [ Time Frame: 3 months ]To observate the efficacy measurements, vital signs, laboratory examinations and adverse events
Secondary Outcome Measures:
- Evaluation criteria [ Time Frame: 6 months ]To evaluate the time to complete epithilization, effectiveness, presence of exudates, presence of prei-lesional erythema, pain intensity and laboratory examination
|Study Start Date:||June 2008|
|Study Completion Date:||May 2010|
|Primary Completion Date:||April 2010 (Final data collection date for primary outcome measure)|
|Active Comparator: Veloderm||
Device: Crystalline cellulose simple occlusive dressing
A natural biological film of vegetable origin. It is classified as skin semi occlusive dressing, as a temporary skin substitute in case of skin lesions or loss.
Other Name: Veloderm
|Placebo Comparator: Vaseline||
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 role, in order to provide an ideal environment for wound epithelialization. As regards safety, 1 adverse reaction occured in test group. It shows effusion under the dressing mild inflammatory infiltration on the wound edge. After the dressing was changed and the effusion was drained, the patient was relieved. As Veloderm dressing itself has no direct anti-inflammatory effects, clinical application as appropriate can plus other anti-infective drugs in accordance with patient conditions. In conclusion, Veloderm is a safe and effective dressing to accelerate the healing of donor sites in burn and plastic surgery. Veloderm can be used as a temporary skin substitute in case of damage of skin or loss of superficial epidermal (such as burns, wounds, abrasions, ulcers, sores and auto-graft donor areas).
Contacts and Locations
No Contacts or Locations Provided