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

Information source: Milliken Healthcare Products, LLC
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Burns; Skin Burn Requiring Skin Graft

Intervention: P6 Low Adherent Dressing (Device); Standard of Care (SOC) (Other)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Milliken Healthcare Products, LLC

Official(s) and/or principal investigator(s):
Bruce Cairns, MD, Principal Investigator, Affiliation: University of North Carolina, Chapel Hill

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.

Clinical Details

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.

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Primary outcome: Management of skin grafts as determined by investigator's visual assessment of percent graft take

Secondary outcome:

The incidence of post-operative graft infections

Assessment of patient's pain / discomfort, using a visual analog scale.

Costs of study burn site wound dressing regimens.

Ease of use and clinician preference of the study burn site wound dressing regimens

Statistical robustness of visual graft take assessments in-person and from digital photographs

Progression of percent graft take with time for both P6 and SOC.

Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Shands at University of Florida, Gainesville, Florida 32610, United States

University of North Carolina, Chapel Hill, Chapel Hill, North Carolina 27599, United States

Wake Forest University Health Sciences, Winston-Salem, North Carolina 27157, United States

University of Tennessee Firefighter's Regional Burn Center, Memphis, Tennessee 38103, United States

Additional Information

Starting date: October 2012
Last updated: July 14, 2014

Page last updated: August 23, 2015

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