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.
Sponsor study identifier
Secondary identifiers
OTHER_GRANT · United States Department of Defense
interventional
80
1 country
4
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
Actual (reported)Study Completion
September 29, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 29, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 24, 2012
Actual (reported)July 31, 2012
Actual (reported)October 2012
Date type not reportedThis date has not been verified as actual or estimated.
September 2014
Actual (reported)September 29, 2017
Actual (reported)Management of skin grafts as determined by investigator's visual assessment of percent graft take
6 days
The incidence of post-operative graft infections
15 days
Assessment of patient's pain / discomfort, using a visual analog scale.
15 days
Costs of study burn site wound dressing regimens.
15 days
Ease of use and clinician preference of the study burn site wound dressing regimens
15 days
Statistical robustness of visual graft take assessments in-person and from digital photographs
15 days
All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the Standard of Care (SOC).
All participants will serve as their own control. All participants will receive both the P6 Low Adherent Dressings and the 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).
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).
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
Bruce Cairns, MD
University of North Carolina, Chapel Hill
First Submitted
July 24, 2012
First Posted
July 31, 2012
Study Start
October 2012
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
September 2014
Actual (reported)ReCell® Combined With Meshed Skin Graft in the Treatment of Acute Burn Injuries
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
Study Completion
September 29, 2017
Actual (reported)Last Updated
October 2, 2017
Record last verified: 2017-09
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Source: ClinicalTrials.gov.
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