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

Sponsor

Lee's Pharmaceutical Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT01512017

Collaborator

Ruijin Hospital (Other), Guangzhou First People's Hospital (Other)

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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).

Study Design

Study Type:

Interventional

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 :

Jun 1, 2008

Actual Primary Completion Date :

Apr 1, 2010

Actual Study Completion Date :

May 1, 2010

Arms and Interventions

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 Names: Veloderm
Placebo Comparator: Vaseline	Device: Vaseline External use

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 Names:

Veloderm

Placebo Comparator: Vaseline

Device: Vaseline

External use

Outcome Measures

Primary Outcome Measures

Response Criteria [3 months]
To observate the efficacy measurements, vital signs, laboratory examinations and adverse events

Secondary Outcome Measures

Evaluation criteria [6 months]
To evaluate the time to complete epithilization, effectiveness, presence of exudates, presence of prei-lesional erythema, pain intensity and laboratory examination

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Lee's Pharmaceutical Limited
Ruijin Hospital
Guangzhou First People's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lee's Pharmaceutical Limited

ClinicalTrials.gov Identifier:

NCT01512017

Other Study ID Numbers:

ZHAOKE-VL2010

First Posted:

Jan 19, 2012

Last Update Posted:

Jan 25, 2012

Last Verified:

Jan 1, 2012

Keywords provided by Lee's Pharmaceutical Limited

skin lesions or defects

Additional relevant MeSH terms:

Petrolatum

Study Results

No Results Posted as of Jan 25, 2012