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

Lee's Pharmaceutical

Status and phase

Completed

Phase 3

Conditions

Split-thickness Skin Graft Donor Sites

Treatments

Device: Crystalline cellulose simple occlusive dressing

Device: Vaseline

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01512017

ZHAOKE-VL2010

Details and patient eligibility

About

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.

Full 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).

Enrollment

96 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.