Skin GraftNCT02543034
Compare of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site
A study testing Betafoam Wound Dressing, Petrolatum Gauze and Allevyn Wound Dressing in people with Skin Graft, run by Mundipharma Korea Ltd at 1 site in South Korea.
Trial summary
This study is a randomized, controlled, multi-centre, open-label, phase IV study. Total 81 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Skin Graft
- What is being tested?
- Betafoam Wound Dressing, Petrolatum Gauze and Allevyn Wound Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Mar 2016to May 2017
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients who is same as or more than 19 years old
- Patients who will receive elective skin harvest operation
- Patients who is in lateral thigh or buttock with donor site area from 50 to 150 cm2
- Female patients who use method of contraception for the study
- Patients who voluntarily sign the informed consent
Who cannot join
- Patients who are pregnant
- Patients who are known to have allergy to the dressing product including PVPI
- Known hyperthyroidism or other thyroid dysfunction such as nodular thyroid goiter, endemic goiter and Hashimoto's thyroiditis or patients who receive radioiodine therapy
- Co-morbidities which may adversely affect wound healing for example a patient with uncontrolled diabetes (HbA1c > 8%), chronic renal failure, autoimmune disease, or immunocompromised patient
- Patients who receive anticoagulants, steroids or immunosuppressants
- Patients who have signs and symptoms of infection on enrollment and adversely affect wound healing
Show all 12Show fewer
- Patients who have skin lesion such as Herpes zoster on donor site
- Burn of >20% total body surface area
- If the donor site had been harvested on a previous occasion
- Patients who is limited cognitive ability
- Patients who are participating in or will plan to participate in other clinical trials
- Other various conditions that the investigators judge inappropriate for enrolment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Controlled, Phase IV Study of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site
This study is a randomized, controlled, multi-centre, open-label, phase IV study.
Total 81 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation.
- Conditions
- Skin Graft
- Being tested
- Betafoam Wound Dressing, Petrolatum Gauze, Allevyn Wound Dressing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Betafoam Wound DressingDevice
Also called Betafoam
Foam dressing including Betadine iodine
Petrolatum GauzeDevice
Gauze dressing
Allevyn Wound DressingDevice
Also called Allevyn
Foam dressing
| Study group | Role | What they receive |
|---|---|---|
| Betafoam Wound Dressing | Experimental | This contains 3% povidone iodine. Dressing will be routinely changed on day 3 and day 7, and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision. Receives: Device: Betafoam Wound Dressing |
| Petrolatum Gauze | Active comparator | Dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision. Receives: Device: Petrolatum Gauze |
| Allevyn Wound Dressing | Active comparator | Allevyn adhesive wound dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision. Receives: Device: Allevyn Wound Dressing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy as measured by speed of wound healing
Days needed for complete skin epithelialization in donor site wounds through routine swab culture (1 and 3 days) and visual assessment of wounds
Measured: 6 months
Secondary outcomes (1)
Efficacy as measured by adverse event collection
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 posted7 Sep 2015 (estimated)
- Study start16 Mar 2016
- Primary completion14 Apr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin GraftStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mundipharma Korea Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jongwon Lee, Dr., Principal investigator, Seoul St. Mary's Hospital, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02543034
- Sponsor's protocol ID
- BTF14-KR-401
- Status last verified
- Nov 2017
- First submitted
- 31 Aug 2015
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Controlled, Phase IV Study of Petrolatum Gauze, Allevyn, and New Dressing, Betafoam® in the Management of Split-Thickness Skin Graft Donor Site
- ClinicalTrials.gov ID
- NCT02543034
- Acronym / sponsor ID
- BTF14-KR-401
- Conditions
- Skin Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Mundipharma Korea LtdIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2016 (actual)
- Primary completion
- 14 Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 7 Sep 2015 (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 randomized, controlled, multi-centre, open-label, phase IV study.
Total 81 patients will be enrolled in this study. Patients will be randomly assigned to Betafoam®, petrolatum gauze or Allevyn for donor site wounds after skin graft operation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Betafoam Wound Dressing | Experimental | Device: Betafoam Wound DressingThis contains 3% povidone iodine. Dressing will be routinely changed on day 3 and day 7, and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision. |
| Petrolatum Gauze | Active comparator | Device: Petrolatum GauzeDressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision. |
| Allevyn Wound Dressing | Active comparator | Device: Allevyn Wound DressingAllevyn adhesive wound dressing will be routinely changed on day 3 and day 7 and can be replaced anytime due to various factors such as exudate control, dislodgement, or by investigators' clinical decision. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients who is same as or more than 19 years old
- Patients who will receive elective skin harvest operation
- Patients who is in lateral thigh or buttock with donor site area from 50 to 150 cm2
- Female patients who use method of contraception for the study
- Patients who voluntarily sign the informed consent
Key exclusion criteria (12 listed)
- Patients who are pregnant
- Patients who are known to have allergy to the dressing product including PVPI
- Known hyperthyroidism or other thyroid dysfunction such as nodular thyroid goiter, endemic goiter and Hashimoto's thyroiditis or patients who receive radioiodine therapy
- Co-morbidities which may adversely affect wound healing for example a patient with uncontrolled diabetes (HbA1c > 8%), chronic renal failure, autoimmune disease, or immunocompromised patient
- Patients who receive anticoagulants, steroids or immunosuppressants
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 |
|---|---|---|
| Betafoam Wound DressingAlso: BetafoamFoam dressing including Betadine iodine | Device | Betafoam Wound Dressing |
| Petrolatum GauzeGauze dressing | Device | Petrolatum Gauze |
| Allevyn Wound DressingAlso: AllevynFoam dressing | Device | Allevyn Wound Dressing |
Primary outcome
Efficacy as measured by speed of wound healing
Time frame: 6 months
Days needed for complete skin epithelialization in donor site wounds through routine swab culture (1 and 3 days) and visual assessment of wounds
1 secondary outcome
Efficacy as measured by adverse event collection
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 7 Nov 2017.
- Individual participant dataSharing planned: No
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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.
Jongwon Lee, Dr. principal investigator
Seoul St. Mary's Hospital, The Catholic University of Korea
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Betafoam Wound Dressing, Petrolatum Gauze and Allevyn Wound Dressing in people with Skin Graft, run by Mundipharma Korea Ltd at 1 site in South Korea.
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 5 inclusion and 12 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 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Efficacy as measured by speed of wound healing (time frame: 6 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 7 Nov 2017.