Exufiber Dressings for Burns

Recruiting at 5 trial locations

Overseen By Jennifer O'Connell

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Molnlycke Health Care AB

Must not be taking: Immunosuppressants, Chemotherapy, Glucocorticosteroids

Disqualifiers: Diabetes, HIV/AIDS, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 9

44 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for individuals with moderate to high exuding partial thickness burns covering less than 5% of their total body. They must have clean wounds, not be diabetic on insulin, and can't have used immunosuppressants or had certain treatments recently. Pregnant people and those unlikely to follow the study plan are excluded.

Inclusion Criteria

Less than 15% of my body is burned, with no more than 10% being severe burns.

Serous or Serosanguinous exudate

My burns cover less than 5% of my body.

Exclusion Criteria

I am not on high doses of steroids, less than 10mg of prednisolone a day.

My burn has worsened to needing surgery under the study treatment.

My wounds are dry.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline and Treatment

Participants are enrolled, and treatment with Exufiber Ag+ or Exufiber dressings begins. Baseline measurements and initial dressing application occur.

3 weeks

5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, with evaluations and dressing changes at each visit.

2 weeks

3 visits (in-person)

Treatment Details

Interventions

• Exufiber
• Exufiber Ag+

Trial Overview The trial tests two types of dressings: Exufiber Ag+ (with silver) and regular Exufiber, on patients with partial thickness burns. It aims to see how well these dressings work over a period of 5 weeks with dressing changes at each visit.

Participant Groups

Group I: Exufiber Ag+ Experimental Treatment 1 Intervention

Treatment with Exufiber Ag+ silver-coated, gelling fiber dressing

Group II: Exufiber Experimental Treatment 1 Intervention

Treatment with Exufiber gelling fiber dressing

Who Is Running the Clinical Trial?

Molnlycke Health Care AB

Lead Sponsor

Trials

57

Recruited

7,900+