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Clinical Study on Veloderm for the Treatment of Split-thickness Skin Graft Donor Sites

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01512017
Recruitment Status : Completed
First Posted : January 19, 2012
Last Update Posted : January 25, 2012
Ruijin Hospital
Guangzhou First People's Hospital
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited

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 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.

Condition or disease Intervention/treatment Phase
Split-thickness Skin Graft Donor Sites Device: Crystalline cellulose simple occlusive dressing Device: Vaseline Phase 3

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 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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
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
Study Start Date : June 2008
Actual Primary Completion Date : April 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Petrolatum

Arm Intervention/treatment
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 Device: Vaseline
External use

Primary Outcome Measures :
  1. Response Criteria [ Time Frame: 3 months ]
    To observate the efficacy measurements, vital signs, laboratory examinations and adverse events

Secondary Outcome Measures :
  1. 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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 with immunosuppressants, antineoplastic drugs and corticosteroids for a long time
  • Subject who has not signed the informed consent form.

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Responsible Party: Lee's Pharmaceutical Limited Identifier: NCT01512017     History of Changes
Other Study ID Numbers: ZHAOKE-VL2010
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: January 25, 2012
Last Verified: January 2012
Keywords provided by Lee's Pharmaceutical Limited:
skin lesions or defects
Additional relevant MeSH terms:
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Dermatologic Agents