Exufiber: A sterile nonwoven wound dressing made from highly absorbent PVA fibers.
Exufiber Ag+: A sterile nonwoven wound dressing made from highly absorbent PVA fibers, and coated with silver sulphate.
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.
Eligibility
Sex
ALL
Min age
4 Weeks
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. Signed informed consent
2. Burn of thermal origin
3. Patients presenting with partial thickness burns covering \< 5% TBSA for study treatment
4. TBSA covered with any burn type is ≤15%, with a maximum of 10% being full thickness burns
5. Clean wounds with ≤10% necrotic tissue
6. Patients presenting with moderate to high exuding wounds
7. Serous or Serosanguinous exudate
8. Patient is not contraindicated for the dressing to which he/she is assigned
Exclusion Criteria:
1. Electrical Burns
2. Chemical Burns including acidic or basic sources
3. Ionizing radiation injuries
4. Dry wounds
5. Neonates
6. Patients with delayed presentation for burn care (\>72 hours from time of injury)
7. Before entry into the study, treatment to the study wound included an active agent that would confound study results, as determined by the Investigator
8. Burns under study treatment transitioning to full thickness, or deep partial thickness burns requiring surgical treatment
9. Clinically infected burn
10. Patients with insulin dependent diabetes mellitus
11. Patients treated with systemic glucocorticosteroids, except patients taking occasional doses or doses less than 10mg prednisolone per day or equivalent
12. Patients who have used immunosuppressive agents, radiation or chemotherapy within past 30 days
13. Known allergy/hypersensitivity to any of the components of the investigation products
14. History of comorbid conditions or diagnoses associated with higher risk of infection as determined by the Investigator
15. Diagnosed underlying disease(s) (e.g. HIV/AIDS, cancer, severe anemia)
16. Patients that are not expected to comply with the investigation due to physical and/or mental conditions
17. Pregnancy
18. Participation in other clinical investigation(s) within 1 month prior to start of the investigation
19. Previously enrolled in this investigation
Primary outcome measure(s)
Wound progression — 5 weeks A subjective measurement to determine wound progression since the last visit, determined by three outcome variables:
Deteriorated
No Change
Improved
Trial sites (6)
Facility
City
Region
Status
Arizona Burn Center, Valleywise Health
Phoenix
Arizona
Keck Medical Center of USC
Los Angeles
California
MedStar Health Research Institute
Washington D.C.
District of Columbia
University of South Florida-Tampa General Hospital
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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