BurnsNCT01654094
Study of Low Adherent Dressing Versus the Standard of Care for the Management of Skin Grafts Over Thermal Burns
A study testing P6 Low Adherent Dressing in people with Burns and Skin Burn Requiring Skin Graft, run by Milliken Healthcare Products, LLC at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the P6 Low Adherent Study Dressing relative to the Standard of Care (SOC, Mafenide Acetate 5% Solution) for the management of skin grafts in burn wounds resulting from thermal burn injuries. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Burns, Skin Burn Requiring Skin Graft
- What is being tested?
- P6 Low Adherent Dressing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 4 sitesUnited States
- Study dates
- Oct 2012to 29 Sep 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients must have thermal burns from scalds, flame/fire or contact with a hot object.
- Patients must have a TBSA burn of less than or equal to 50%.
- Patients must have two nonadjacent study burn sites (i.e., separated in such a way that SOC dressing does not contaminate the study dressing) of comparable size (up to approximately 2% TBSA) and severity requiring excision and grafting.
- Patients must have undergone excision and autografting on or before post-burn day (PBD) 14.
- Patients' study burn sites will be treated with skin grafts with a mesh ratio up to 3:1, at the surgeon's discretion.
- Patients expected to be available for assessment of study burn sites at least until POD 6 ±1 day.
- Males or females at least 18 years of age but no older than 65 years of age at the time of informed consent.
- Patient and / or Legally Authorized Representative (LAR) voluntarily agrees to provide written informed consent and the willingness and ability to comply with all aspects of the protocol.
Who cannot join
- Patients with electrical or chemical burns.
- Patients with a study burn site excised and "grafted" with Integra.
- Patients with study burn sites on the buttocks, scalp, hands, feet, neck or ears.
- Patients taking vasopressors or inotropes.
- Patients using systemic immunosuppressants (e.g., corticosteroids and anti-neoplastic agents, etc.).
- Patients with acute renal failure, defined as creatinine clearance (CrCL) >2.5 mg/dL or AKIN score greater than or equal to 2 or estimated GFR < 30, if the assessment is conducted as part of the patient's routine clinical care.
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- Patients with acute respiratory distress syndrome (ARDS), if the assessment is conducted as part of the patient's routine clinical care.
- Patients with liver cirrhosis (Childs-Pugh B Class or greater) or who have AST / ALT levels greater than or equal to 2 times the upper limit of theinstitution's normal range, if the assessment is conducted as part of the patient's routine clinical care.
- Patients with a known sensitivity or known intolerance to mafenide acetate (Sulfamylon) or to silver.
- Patients with any concurrent medical condition, which in the opinion of the investigator, may compromise their safety or the objectives of the study.
- Patients who are breastfeeding, pregnant or expecting to become pregnant during the study..
- Patients who have been exposed to an investigational drug or device within 30 days prior to Screening or is scheduled to receive another investigational drug or device during either the Treatment Phase or Follow-up Evaluation.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, 27599
Shands at University of Florida
Gainesville, Florida, 32610
University of Tennessee Firefighter's Regional Burn Center
Memphis, Tennessee, 38103
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157
About this study
Official title: A Multicenter, Prospective, Randomized Study to Compare Milliken Dressing P6 to Mafenide Acetate 5% Solution as a Split Thickness Skin Graft Cover Dressing in Burn Wound Patients.
The purpose of this study is to evaluate the P6 Low Adherent Study Dressing relative to the Standard of Care (SOC, Mafenide Acetate 5% Solution) for the management of skin grafts in burn wounds resulting from thermal burn injuries.
- Conditions
- Burns, Skin Burn Requiring Skin Graft
- Being tested
- P6 Low Adherent Dressing, Standard of Care (SOC)
- Medical subject headings
- Burns
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P6 Low Adherent DressingDevice
Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC).
Standard of Care (SOC)Other
Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC).
| Study group | Role | What they receive |
|---|---|---|
| P6 Low Adherent Dressing | Experimental | All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC). Receives: Device: P6 Low Adherent Dressing |
| Standard of Care (SOC) | Active comparator | All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC). Receives: Other: Standard of Care (SOC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Management of skin grafts as determined by investigator's visual assessment of percent graft take
Measured: 6 days
Secondary outcomes (7)
The incidence of post-operative graft infections
Measured: 15 days
Assessment of patient's pain / discomfort, using a visual analog scale.
Measured: 15 days
Costs of study burn site wound dressing regimens.
Measured: 15 days
Ease of use and clinician preference of the study burn site wound dressing regimens
Measured: 15 days
Statistical robustness of visual graft take assessments in-person and from digital photographs
Measured: 15 days
Progression of percent graft take with time for both P6 and SOC.
Measured: 15 days
Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions.
Measured: 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2012 (estimated)
- Study startOct 2012
- Primary completionSep 2014
- Study completion29 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BurnsStudies 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Milliken Healthcare Products, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Criterium, Inc., U.S. Army Medical Research and Development Command
- Responsible party
- Sponsor
- Investigators
- Bruce Cairns, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01654094
- Sponsor's protocol ID
- MHP-P6-1
- Other IDs
- W81XWH-10-2-0159
- Status last verified
- Sep 2017
- First submitted
- 24 Jul 2012
- Last updated
- 2 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Randomized Study to Compare Milliken Dressing P6 to Mafenide Acetate 5% Solution as a Split Thickness Skin Graft Cover Dressing in Burn Wound Patients.
- ClinicalTrials.gov ID
- NCT01654094
- Acronym / sponsor ID
- MHP-P6-1
- Conditions
- Burns, Skin Burn Requiring Skin Graft
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Milliken Healthcare Products, LLCIndustry (pharma, biotech, devices)
- Collaborators
- Criterium, Inc., U.S. Army Medical Research and Development Command
- Study start
- Oct 2012
- Primary completion
- Sep 2014 (actual)
- Study completion
- 29 Sep 2017 (actual)
- First posted
- 31 Jul 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.
The purpose of this study is to evaluate the P6 Low Adherent Study Dressing relative to the Standard of Care (SOC, Mafenide Acetate 5% Solution) for the management of skin grafts in burn wounds resulting from thermal burn injuries.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| P6 Low Adherent Dressing | Experimental | Device: P6 Low Adherent DressingAll participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC). |
| Standard of Care (SOC) | Active comparator | Other: Standard of Care (SOC)All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients must have thermal burns from scalds, flame/fire or contact with a hot object.
- Patients must have a TBSA burn of less than or equal to 50%.
- Patients must have two nonadjacent study burn sites (i.e., separated in such a way that SOC dressing does not contaminate the study dressing) of comparable size (up to approximately 2% TBSA) and severity requiring excision and grafting.
- Patients must have undergone excision and autografting on or before post-burn day (PBD) 14.
- Patients' study burn sites will be treated with skin grafts with a mesh ratio up to 3:1, at the surgeon's discretion.
Key exclusion criteria (12 listed)
- Patients with electrical or chemical burns.
- Patients with a study burn site excised and "grafted" with Integra.
- Patients with study burn sites on the buttocks, scalp, hands, feet, neck or ears.
- Patients taking vasopressors or inotropes.
- Patients using systemic immunosuppressants (e.g., corticosteroids and anti-neoplastic agents, etc.).
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 |
|---|---|---|
| P6 Low Adherent DressingEach patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC). | Device | P6 Low Adherent Dressing |
| Standard of Care (SOC)Each patient will have two similar, non-adjacent study sites. One site will be treated with P6 Low Adherent Dressing and the other site will be treated with the Standard of Care (SOC). | Other | Standard of Care (SOC) |
Primary outcome
Management of skin grafts as determined by investigator's visual assessment of percent graft take
Time frame: 6 days
7 secondary outcomes
The incidence of post-operative graft infections
Time frame: 15 days
Assessment of patient's pain / discomfort, using a visual analog scale.
Time frame: 15 days
Costs of study burn site wound dressing regimens.
Time frame: 15 days
Ease of use and clinician preference of the study burn site wound dressing regimens
Time frame: 15 days
Statistical robustness of visual graft take assessments in-person and from digital photographs
Time frame: 15 days
Progression of percent graft take with time for both P6 and SOC.
Time frame: 15 days
Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions.
Time frame: 15 days
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 2 Oct 2017.
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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.
Bruce Cairns, MD principal investigator
University of North Carolina, Chapel Hill
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing P6 Low Adherent Dressing in people with Burns and Skin Burn Requiring Skin Graft, run by Milliken Healthcare Products, LLC at 4 sites in United States.
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 8 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 2 Oct 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Management of skin grafts as determined by investigator's visual assessment of percent graft take (time frame: 6 days). 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 2 Oct 2017.