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

NCT01654094 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2017-10-02

No results posted yet for this study

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.

Conditions

  • Burns
  • Skin Burn Requiring Skin Graft

Interventions

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).

Sponsors & Collaborators

  • Criterium, Inc.

    collaborator INDUSTRY

  • U.S. Army Medical Research and Development Command

    collaborator FED

  • Milliken Healthcare Products, LLC

    lead INDUSTRY

Principal Investigators

  • Bruce Cairns, MD · University of North Carolina, Chapel Hill

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-10-31
Primary Completion
2014-09-30
Completion
2017-09-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01654094 on ClinicalTrials.gov