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

Running, not enrolling · Not applicable

Conditions studied: Partial-thickness Burn

In brief

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.

Key facts

Study ID

NCT04839523

Run by

Molnlycke Health Care AB

People needed

44

Starts

2021-03-10

Expected to finish

2024-12-31

Last updated by the study team

2024-11-12

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Signed informed consent
• Burn of thermal origin
• Patients presenting with partial thickness burns covering < 5% TBSA for study treatment
• TBSA covered with any burn type is ≤15%, with a maximum of 10% being full thickness burns
• Clean wounds with ≤10% necrotic tissue
• Patients presenting with moderate to high exuding wounds
• Serous or Serosanguinous exudate
• Patient is not contraindicated for the dressing to which he/she is assigned

You may not qualify if…

• Electrical Burns
• Chemical Burns including acidic or basic sources
• Ionizing radiation injuries
• Dry wounds
• Neonates
• Patients with delayed presentation for burn care (>72 hours from time of injury)
• Before entry into the study, treatment to the study wound included an active agent that would confound study results, as determined by the Investigator
• Burns under study treatment transitioning to full thickness, or deep partial thickness burns requiring surgical treatment
• Clinically infected burn
• Patients with insulin dependent diabetes mellitus
• Patients treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone per day or equivalent
• Patients who have used immunosuppressive agents, radiation or chemotherapy within past 30 days
• Known allergy/hypersensitivity to any of the components of the investigation products
• History of comorbid conditions or diagnoses associated with higher risk of infection as determined by the Investigator
• Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer, severe anemia)
• Patients that are not expected to comply with the investigation due to physical and/or mental conditions
• Pregnancy
• Participation in other clinical investigation(s) within 1 month prior to start of the investigation
• Previously enrolled in this investigation

Where it is running

• 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

Full record on ClinicalTrials.gov

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