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

This study has been completed.
Sponsor:
Collaborators:
Ruijin Hospital
Guangzhou First Municipal People’s Hospital
Information provided by (Responsible Party):
Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier:
NCT01512017
First received: September 14, 2010
Last updated: January 24, 2012
Last verified: January 2012
  Purpose

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 Intervention Phase
Split-thickness Skin Graft Donor Sites
Device: Crystalline cellulose simple occlusive dressing
Device: Vaseline
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Lee's Pharmaceutical Limited:

Primary Outcome Measures:
  • Response Criteria [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    To observate the efficacy measurements, vital signs, laboratory examinations and adverse events


Secondary Outcome Measures:
  • Evaluation criteria [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    To evaluate the time to complete epithilization, effectiveness, presence of exudates, presence of prei-lesional erythema, pain intensity and laboratory examination


Enrollment: 96
Study Start Date: June 2008
Study Completion Date: May 2010
Primary Completion Date: April 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Lee's Pharmaceutical Limited
ClinicalTrials.gov Identifier: NCT01512017     History of Changes
Other Study ID Numbers: ZHAOKE-VL2010
Study First Received: September 14, 2010
Last Updated: January 24, 2012
Health Authority: China: Food and Drug Administration

Keywords provided by Lee's Pharmaceutical Limited:
skin lesions or defects

ClinicalTrials.gov processed this record on September 22, 2014