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Recruiting
NCT05089890
Clinical Investigation of Sorbact® Dressings
Conditions: Hard-to-heal Wounds, Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Arterial Leg Ulcer
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 30
Sponsor: ABIGO Medical AB
Location: Sahlgrenska University Hospital Mölndal
Summary
The main purpose of this exploratory clinical investigation is to study the binding of bacteria and fungi from hard-to-heal wounds to the DACC-coated dressings.
Eligibility Criteria
Inclusion Criteria:
1. Able to read and understand the Subject Information and Informed Consent Form and provide meaningful informed consent
2. Due to start using one of the following dressings: Sorbact® Compress, Sorbact® Gel Dressing and Sorbact® Ribbon Gauze
3. Age ≥18 years
4. Presence of hard-to-heal wound for ≥6 weeks with no significant wound area reduction for the last 4 weeks confirmed by investigator/study nurse
Exclusion Criteria:
1. Participating in another clinical investigation
2. Known allergy or sensitivity to any components of the allocated investigational device
3. Use of antimicrobial agent (e.g., silver- or iodine-containing dressings, or gels) during the last wo weeks
4. Use of a dressing from the Sorbact® range during the last two weeks
5. Subjects with any other condition that as judged by the investigator may make investigation procedures inappropriate
Source: ClinicalTrials.gov (NCT05089890). StuddyBuddy aggregates publicly available trial information.