Burns, Skin Burn Requiring Skin Graft
Conditions
Brief 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.
Interventions
DEVICEP6 Low Adherent Dressing
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).
OTHERStandard 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).
Sponsors
Criterium, Inc.
U.S. Army Medical Research and Development Command
Milliken Healthcare Products, LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Management of skin grafts as determined by investigator's visual assessment of percent graft take | 6 days |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| The incidence of post-operative graft infections | 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 |
| Statistical robustness of visual graft take assessments in-person and from digital photographs | 15 days |
Countries
United States
Outcome results
None listed