Clinical trial NCT01654094: Study of Low Adherent Dressing Versus the Standard of Care for the Management of Skin Grafts Over Thermal Burns
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Burns
Skin Burn Requiring Skin Graft
Lead sponsor: Milliken Healthcare Products, LLC
Sponsor class: INDUSTRY
Collaborators: name: Criterium, Inc.
name: U.S. Army Medical Research and Development Command
First posted: 2012-07-31
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


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.

Primary outcomes:
measure: Management of skin grafts as determined by investigator's visual assessment of percent graft take
timeFrame: 6 days
Secondary outcomes:
measure: The incidence of post-operative graft infections
timeFrame: 15 days
measure: Assessment of patient's pain / discomfort, using a visual analog scale.
timeFrame: 15 days
measure: Costs of study burn site wound dressing regimens.
timeFrame: 15 days
measure: Ease of use and clinician preference of the study burn site wound dressing regimens
timeFrame: 15 days
measure: Statistical robustness of visual graft take assessments in-person and from digital photographs
timeFrame: 15 days
measure: Progression of percent graft take with time for both P6 and SOC.
timeFrame: 15 days
measure: Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions.
timeFrame: 15 days
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands at University of Florida
state: Florida
city: Chapel Hill
country: United States
facility: University of North Carolina, Chapel Hill
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Memphis
country: United States
facility: University of Tennessee Firefighter's Regional Burn Center
state: Tennessee
Study officials:
affiliation: University of North Carolina, Chapel Hill
name: Bruce Cairns, MD
role: PRINCIPAL_INVESTIGATOR
References: