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

NCT ID: NCT01654094

Last Updated: 2017-10-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-10-31
• Study Completion Date: 2017-09-29

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.

Conditions

Burns; Skin Burn Requiring Skin Graft

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

P6 Low Adherent Dressing

All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC).

Group Type: EXPERIMENTAL

P6 Low Adherent Dressing

Intervention Type: DEVICE

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)

All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC).

Group Type: ACTIVE_COMPARATOR

Standard of Care (SOC)

Intervention Type: 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).

Interventions

P6 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).

Intervention Type: DEVICE

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).

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Criterium, Inc.

INDUSTRY

Sponsor Role: collaborator

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Milliken Healthcare Products, LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruce Cairns, MD

Role: PRINCIPAL_INVESTIGATOR

University of North Carolina, Chapel Hill

Locations

Shands at University of Florida

Gainesville, Florida, United States

University of North Carolina, Chapel Hill

Chapel Hill, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

University of Tennessee Firefighter's Regional Burn Center

Memphis, Tennessee, United States

Countries

United States

Other Identifiers

W81XWH-10-2-0159

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

MHP-P6-1

Identifier Type: -

Identifier Source: org_study_id