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

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.

Study Overview

• Status: Completed
• Conditions: Burns; Skin Burn Requiring Skin Graft
• Intervention / Treatment: Device: P6 Low Adherent Dressing; Other: Standard of Care (SOC)

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Shands at University of Florida
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27599
      • University of North Carolina, Chapel Hill
    • Winston-Salem, North Carolina, United States, 27157
      • Wake Forest University Health Sciences
  • Tennessee
    • Memphis, Tennessee, United States, 38103
      • University of Tennessee Firefighter's Regional Burn Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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).	Device: 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).
ACTIVE_COMPARATOR: 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).	Other: 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).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Milliken Healthcare Products, LLC
• Collaborators: U.S. Army Medical Research and Development Command; Criterium, Inc.

Study record dates

Study Major Dates

• Study Start: October 1, 2012
• Primary Completion (ACTUAL): September 1, 2014
• Study Completion (ACTUAL): September 29, 2017

Study Registration Dates

• First Submitted: July 24, 2012
• First Submitted That Met QC Criteria: July 30, 2012
• First Posted (ESTIMATE): July 31, 2012

Study Record Updates

• Last Update Posted (ACTUAL): October 2, 2017
• Last Update Submitted That Met QC Criteria: September 29, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Burns
• Other Study ID Numbers: MHP-P6-1; W81XWH-10-2-0159 (OTHER_GRANT: United States Department of Defense)