Study of Low Adherent Dressing Versus the Standard of Care for the Management of Skin Grafts Over Thermal Burns

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Burns, Skin Burn Requiring Skin Graft

Intervention / Treatment
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* Device: P6 Low Adherent Dressing
* Other: Standard of Care (SOC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P6 Low Adherent Dressing<br>All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC). | Device: P6 Low Adherent Dressing<br>* 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).<br>|
| Active Comparator: Standard of Care (SOC)<br>All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC). | Other: Standard of Care (SOC)<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Management of skin grafts as determined by investigator's visual assessment of percent graft take |  | 6 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of post-operative graft infections |  | 15 days | 
| Assessment of patient's pain / discomfort, using a visual analog scale. |  | 15 days | 
| Costs of study burn site wound dressing regimens. |  | 15 days | 
| Ease of use and clinician preference of the study burn site wound dressing regimens |  | 15 days | 
| Statistical robustness of visual graft take assessments in-person and from digital photographs |  | 15 days | 
| Progression of percent graft take with time for both P6 and SOC. |  | 15 days | 
| Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions. |  | 15 days |