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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Criterium Inc.
U.S. Army Medical Research and Materiel Command
Information provided by (Responsible Party):
Milliken Healthcare Products, LLC
ClinicalTrials.gov Identifier:
NCT01654094
First received: July 24, 2012
Last updated: July 14, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention
Burns
Skin Burn Requiring Skin Graft
Device: P6 Low Adherent Dressing
Other: Standard of Care (SOC)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Milliken Healthcare Products, LLC:

Primary Outcome Measures:
  • Management of skin grafts as determined by investigator's visual assessment of percent graft take [ Time Frame: 6 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The incidence of post-operative graft infections [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Assessment of patient's pain / discomfort, using a visual analog scale. [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Costs of study burn site wound dressing regimens. [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Ease of use and clinician preference of the study burn site wound dressing regimens [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Statistical robustness of visual graft take assessments in-person and from digital photographs [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Progression of percent graft take with time for both P6 and SOC. [ Time Frame: 15 days ] [ Designated as safety issue: No ]
  • Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions. [ Time Frame: 15 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 80
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01654094

Locations
United States, Florida
Shands at University of Florida
Gainesville, Florida, United States, 32610
United States, North Carolina
University of North Carolina, Chapel Hill
Chapel Hill, North Carolina, United States, 27599
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Tennessee
University of Tennessee Firefighter's Regional Burn Center
Memphis, Tennessee, United States, 38103
Sponsors and Collaborators
Milliken Healthcare Products, LLC
Criterium Inc.
U.S. Army Medical Research and Materiel Command
Investigators
Principal Investigator: Bruce Cairns, MD University of North Carolina, Chapel Hill
  More Information

No publications provided

Responsible Party: Milliken Healthcare Products, LLC
ClinicalTrials.gov Identifier: NCT01654094     History of Changes
Other Study ID Numbers: MHP-P6-1, W81XWH-10-2-0159
Study First Received: July 24, 2012
Last Updated: July 14, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Additional relevant MeSH terms:
Burns
Wounds and Injuries

ClinicalTrials.gov processed this record on September 16, 2014