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Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
Sponsor: Molnlycke Health Care AB
Summary
This a multi-center, open label, non-comparative, study that will evaluate the clinical safety and performance of Exufiber Ag+ and Exufiber dressings, separately, when used as intended in moderate to high exuding partial thickness burns (PTBs) through assessment of wound progression from baseline to the Subject's last clinical follow-up visit. Sixty-eight (68) eligible subjects, with moderate to high exuding partial-thickness burns, will be selected for treatment with either Exufiber Ag+ silver-coated gelling dressing, or Exufiber gelling dressing. The study will last 5 weeks, with a requirement of 5 study visits in total, including dressing changes at each study visit.
Official title: An Open, Non-comparative, Multi-center Investigation to Evaluate Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
Key Details
Gender
All
Age Range
4 Weeks - Any
Study Type
INTERVENTIONAL
Enrollment
44
Start Date
2021-03-10
Completion Date
2024-12-31
Last Updated
2024-11-12
Healthy Volunteers
No
Conditions
Interventions
Exufiber
A sterile nonwoven wound dressing made from highly absorbent PVA fibers.
Exufiber Ag+
A sterile nonwoven wound dressing made from highly absorbent PVA fibers, and coated with silver sulphate.
Locations (6)
Arizona Burn Center, Valleywise Health
Phoenix, Arizona, United States
Keck Medical Center of USC
Los Angeles, California, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, United States
University of South Florida-Tampa General Hospital
Tampa, Florida, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Drexel Univerisity
Philadelphia, Pennsylvania, United States