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Clinical Trial 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.


Clinical Trial 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 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). ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms

  • Split-thickness Skin Graft Donor Sites

NCT number NCT01512017
Study type Interventional
Source Lee's Pharmaceutical Limited
Contact
Status Completed
Phase Phase 3
Start date June 2008
Completion date May 2010

See also
  Status Clinical Trial Phase
Withdrawn NCT00392301 - Split-Thickness Skin Graft Donor Site Wound Healing Study N/A
Withdrawn NCT02712164 - Molecular, Histologic, and Clinical Analysis of Negative Pressure Wound Therapy (NPWT) for Split-thickness Skin Graft (STSG) Donor Sites N/A
Completed NCT02642679 - Evaluation of Opticell Ag on Split-Thickness Skin Graft Donor Sites in Adult Subjects N/A