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

Milliken Healthcare Products

Status

Completed

Conditions

Skin Burn Requiring Skin Graft

Burns

Treatments

Other: Standard of Care (SOC)

Device: P6 Low Adherent Dressing

Study type

Interventional

Funder types

Industry

Other U.S. Federal agency

Identifiers

NCT01654094

W81XWH-10-2-0159 (Other Grant/Funding Number)

MHP-P6-1

Details and patient eligibility

About

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.

Enrollment

80 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.