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



Status:Completed
Conditions:Other Indications, Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 65
Updated:10/4/2017
Start Date:October 2012
End Date:September 29, 2017

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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.


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.
We found this trial at
4
sites
1 Medical Center Blvd
Winston-Salem, North Carolina 27157
336-716-2011
Wake Forest University Health Sciences Welcome to Wake Forest Baptist Medical Center, a fully integrated...
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Chapel Hill, North Carolina 27599
(919) 962-2211
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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Gainesville, Florida 32610
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Memphis, TN
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