NCT01654094

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

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.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Milliken Healthcare Products, LLC · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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).

Timeline

• Start date: 2012-10-01
• Primary completion: 2014-09-01
• Completion: 2017-09-29
• First posted: 2012-07-31
• Last updated: 2017-10-02

Locations

4 sites across 1 country: United States