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ACTIVE NOT RECRUITING
NCT04839523
NA

Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns

Sponsor: Molnlycke Health Care AB

View on ClinicalTrials.gov

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

Interventions

DEVICE

Exufiber

A sterile nonwoven wound dressing made from highly absorbent PVA fibers.

DEVICE

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