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

Burns Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01654094
• Other study ID #: MHP-P6-1
• Secondary ID: W81XWH-10-2-0159
• Status: Completed
• Phase: N/A
• First received: July 24, 2012
• Last updated: September 29, 2017
• Start date: October 2012
• Est. completion date: September 29, 2017

Study information

• Verified date: September 2017
• Source: Milliken Healthcare Products, LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 29, 2017
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burns
• Skin Burn Requiring Skin Graft

Intervention

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).

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).

Locations

Country	Name	City	State
United States	University of North Carolina, Chapel Hill	Chapel Hill	North Carolina
United States	Shands at University of Florida	Gainesville	Florida
United States	University of Tennessee Firefighter's Regional Burn Center	Memphis	Tennessee
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (3)

Lead Sponsor	Collaborator
Milliken Healthcare Products, LLC	Criterium, Inc., U.S. Army Medical Research and Materiel Command

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Management of skin grafts as determined by investigator's visual assessment of percent graft take		6 days
Secondary	The incidence of post-operative graft infections		15 days
Secondary	Assessment of patient's pain / discomfort, using a visual analog scale.		15 days
Secondary	Costs of study burn site wound dressing regimens.		15 days
Secondary	Ease of use and clinician preference of the study burn site wound dressing regimens		15 days
Secondary	Statistical robustness of visual graft take assessments in-person and from digital photographs		15 days
Secondary	Progression of percent graft take with time for both P6 and SOC.		15 days
Secondary	Assessment of the incidence and severity of SAEs and wound specific AEs, including local reactions.		15 days