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Clinical Investigation of Sorbact® Dressings
RECRUITINGN/ASponsored by ABIGO Medical AB
Actively Recruiting
PhaseN/A
SponsorABIGO Medical AB
Started2025-04-05
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05089890
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
Age: 18 Years+Healthy volunteers accepted
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
Conditions6
Arterial Leg UlcerDiabetesDiabetic Foot UlcerHard-to-heal WoundsPressure UlcerVenous Leg Ulcer
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Actively Recruiting
PhaseN/A
SponsorABIGO Medical AB
Started2025-04-05
Est. completion2026-12
Eligibility
Age18 Years+
Healthy vol.Accepted
View on ClinicalTrials.gov →
NCT05089890