Status:
COMPLETED
Evaluation of Exufiber Ag+ and Other Gelling Fibre Dressings
Lead Sponsor:
Molnlycke Health Care AB
Conditions:
Wounds and Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Investigate impact of gelling fiber dressings on handling exudate in medium to high exuding wounds
Eligibility Criteria
Inclusion
- Signed Informed Consent Form
- Both gender ≥ 18 years old
- From Medium to High exuding wound
Exclusion
- Known allergy or hypersensitivity to any of the treatment dressings
- Pregnant or lactating females
- Subjects with a target wound that is ≤1 cm2
- Subjects with a target wound that is a full thickness burn
- Subjects with a target wound that is a full thickness pressure ulcer
- Subjects with known immunodeficiency
- Subject taking systemic antibiotics for wound infection
- Subject were the target wound is located on an infected limb interfered by minimal blood flow in the opinion of the investigator
- Subject with a target wound with unexplored enteric fistula
- Subjects who in the opinion of the investigator, will have problems following the protocol
- Subjects needing treatment with oxidizing agents such as hypochlorite solutions or hydrogen peroxide
- Previously enrolled in the present investigation
- Inclusion in other ongoing investigations at present that would preclude the subject from participating in this investigation as judged by the investigator
- Involvement in the planning and conduct of the clinical investigation
Key Trial Info
Start Date :
August 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 19 2019
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT03249909
Start Date
August 11 2017
End Date
August 19 2019
Last Update
September 29 2020
Active Locations (8)
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1
Midwestern University
Glendale, Arizona, United States, 85308
2
Center for Clinical Research, Inc.
San Francisco, California, United States, 94115
3
University of Miami
Miami, Florida, United States, 33125
4
University of South Florida
Tampa, Florida, United States, 33606