Clinical Trial

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

Active, Not Recruiting
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Record status
This record was last updated November 12, 2024 (before its estimated December 31, 2024 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-04-07; most recent amendment 2024-11-07.
Status change: Recruiting → Active, Not Recruiting 2024-11-07
Trial Details
NCT Number NCT04839523
Lead Sponsor Molnlycke Health Care AB
Conditions Partial-thickness Burn
Enrollment 44 participants
Start Date 2021-03-10
Primary Completion 2024-12-31 (estimated)
Study Completion 2024-12-31 (estimated)
Updated on ClinicalTrials.gov 2024-11-12