Split-thickness Skin Graft Donor SitesPhase 3NCT01512017
Clinical Study on Veloderm for the Treatment of Split-thickness Skin Graft Donor Sites
A Phase 3 study testing Crystalline cellulose simple occlusive dressing and Vaseline in people with Split-thickness Skin Graft Donor Sites, run by Lee's Pharmaceutical Limited.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Split-thickness Skin Graft Donor Sites
- What is being tested?
- Crystalline cellulose simple occlusive dressing and Vaseline
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Jun 2008to May 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
About this study
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
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.
Read the 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).
- Conditions
- Split-thickness Skin Graft Donor Sites
- Being tested
- Crystalline cellulose simple occlusive dressing, Vaseline
- Keywords
- skin lesions or defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Crystalline cellulose simple occlusive dressingDevice
Also called Veloderm
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.
VaselineDevice
External use
| Study group | Role | What they receive |
|---|---|---|
| Veloderm | Active comparator | Not described Receives: Device: Crystalline cellulose simple occlusive dressing |
| Vaseline | Placebo comparator | Not described Receives: Device: Vaseline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response Criteria
To observate the efficacy measurements, vital signs, laboratory examinations and adverse events
Measured: 3 months
Secondary outcomes (1)
Evaluation criteria
To evaluate the time to complete epithilization, effectiveness, presence of exudates, presence of prei-lesional erythema, pain intensity and laboratory examination
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2012 (estimated)
- Study startJun 2008
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Split-thickness Skin Graft Donor SitesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lee's Pharmaceutical Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital, Guangzhou First People's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01512017
- Sponsor's protocol ID
- ZHAOKE-VL2010
- Status last verified
- Jan 2012
- First submitted
- 14 Sep 2010
- Last updated
- 25 Jan 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01512017
- Acronym / sponsor ID
- ZHAOKE-VL2010
- Conditions
- Split-thickness Skin Graft Donor Sites
- Keywords
- skin lesions or defects
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Lee's Pharmaceutical LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Ruijin Hospital, Guangzhou First People's Hospital
- Study start
- Jun 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 19 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veloderm | Active comparator | Device: Crystalline cellulose simple occlusive dressing |
| Vaseline | Placebo comparator | Device: Vaseline |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Crystalline cellulose simple occlusive dressingAlso: VelodermA 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. | Device | Veloderm |
| VaselineExternal use | Device | Vaseline |
Primary outcome
Response Criteria
Time frame: 3 months
To observate the efficacy measurements, vital signs, laboratory examinations and adverse events
1 secondary outcome
Evaluation criteria
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Crystalline cellulose simple occlusive dressing and Vaseline in people with Split-thickness Skin Graft Donor Sites, run by Lee's Pharmaceutical Limited.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Response Criteria (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2012.