Overview

This trial is active, not recruiting.

Conditions burns, skin burn requiring skin graft
Treatments p6 low adherent dressing, standard of care (soc)
Sponsor Milliken Healthcare Products, LLC
Collaborator Criterium Inc.
Start date October 2012
End date September 2014
Trial size 80 participants
Trial identifier NCT01654094, MHP-P6-1, W81XWH-10-2-0159

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC).
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)
All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC).
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).

Primary Outcomes

Measure
Management of skin grafts as determined by investigator's visual assessment of percent graft take
time frame: 6 days

Secondary Outcomes

Measure
The incidence of post-operative graft infections
time frame: 15 days
Assessment of patient's pain / discomfort, using a visual analog scale.
time frame: 15 days
Costs of study burn site wound dressing regimens.
time frame: 15 days
Ease of use and clinician preference of the study burn site wound dressing regimens
time frame: 15 days
Statistical robustness of visual graft take assessments in-person and from digital photographs
time frame: 15 days
Progression of percent graft take with time for both P6 and SOC.
time frame: 15 days
Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions.
time frame: 15 days

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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.

Additional Information

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.
Principal investigator Bruce Cairns, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2014.
Information provided to ClinicalTrials.gov by Milliken Healthcare Products, LLC.