UnknownNot Applicable

Clinical Investigation of Sorbact® Dressings

30 participantsStarted 2021-10

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Able to read and understand the Subject Information and Informed Consent Form and provide meaningful informed consent
✓. Due to start using one of the following dressings: Sorbact® Compress, Sorbact® Gel Dressing and Sorbact® Ribbon Gauze
✓. Age ≥18 years
✓. 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

✕. Participating in another clinical investigation
✕. Known allergy or sensitivity to any components of the allocated investigational device
✕. Use of systemic or topical antibiotic for the past two weeks or planning to use while participating in investigation.
✕. Use of antimicrobial agent (e.g., silver- or iodine-containing dressings, or gels) during the last wo weeks
✕. Use of a dressing from the Sorbact® range during the last two weeks
✕. Subjects with any other condition that as judged by the investigator may make investigation procedures inappropriate

What they're measuring

Bacterial and fungal species irreversibly bound to the dressing after 2 days (+ 1 day).

Timeframe: 2 days (+1 day)

Trial details

NCT IDNCT05089890

SponsorABIGO Medical AB

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-02-28

Contact for this trial

Fana Hunegnaw

+46761361512 fana.hunegnaw@abigo.com

View on ClinicalTrials.gov More Hard-to-heal Wounds trials