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

NCT01512017 | Completed Phase 3 DMC

• 1 other identifier: ZHAOKE-VL2010
• Study Type: interventional
• Target: 96
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Split-thickness Skin Graft Donor Sites

Keywords

skin lesions or defects

Outcome Measures

Primary Outcomes (1)

• Response Criteria

  To observate the efficacy measurements, vital signs, laboratory examinations and adverse events

  3 months

Secondary Outcomes (1)

• Evaluation criteria

  6 months

Study Arms (2)

Veloderm

ACTIVE COMPARATOR

Device: Crystalline cellulose simple occlusive dressing

Vaseline

PLACEBO COMPARATOR

Device: Vaseline

Interventions

Crystalline cellulose simple occlusive dressing DEVICE

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.

Also known as: Veloderm

Veloderm

Vaseline DEVICE

External use

Vaseline

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lee's Pharmaceutical Limited: lead
• Ruijin Hospital: collaborator
• Guangzhou First People's Hospital: collaborator

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2010
• First Posted: January 19, 2012
• Study Start: June 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: May 1, 2010
• Last Updated: January 25, 2012

Record last verified: 2012-01