Status:
ACTIVE_NOT_RECRUITING
Performance and Safety of Exufiber Ag+ and Exufiber on Partial Thickness Burns
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Partial-thickness Burn
Eligibility:
All Genders
4+ years
Phase:
NA
Brief 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 ...
Detailed Description
This is a multi-center study taking place in the United States, and conducted at 3-4 sites/locations. It is designed as an open, non-comparative study to test the safety and performance of Exufiber Ag...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
March 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2024
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT04839523
Start Date
March 10 2021
End Date
December 31 2024
Last Update
November 12 2024
Active Locations (6)
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1
Arizona Burn Center, Valleywise Health
Phoenix, Arizona, United States, 85008
2
Keck Medical Center of USC
Los Angeles, California, United States, 90033
3
MedStar Health Research Institute
Washington D.C., District of Columbia, United States, 20010
4
University of South Florida-Tampa General Hospital
Tampa, Florida, United States, 33606