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

NCT04839523 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2024-11-12

No results posted yet for this study

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.

Conditions

  • Partial-thickness Burn

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.

Sponsors & Collaborators

  • Molnlycke Health Care AB

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
4 Weeks
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2024-12-31
Completion
2024-12-31
FDA Device
Yes

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 NCT04839523 on ClinicalTrials.gov