Clinical Investigation of Sorbact® Dressings

ABIGO Medical

Status: Unknown

Conditions: Venous Leg Ulcer; Hard-to-heal Wounds; Pressure Ulcer; Arterial Leg Ulcer; Diabetic Foot Ulcer

Treatments: Device: Sorbact® Ribbon Gauze; Device: Sorbact® Gel Dressing; Device: Sorbact® Compress

Study type: Interventional

Funder types: Industry

Identifiers

NCT05089890

DHF-5474

Details and patient eligibility

About

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.

Full description

This is a prospective, open, single-centre, exploratory clinical investigation with a primary objective of studying the binding of bacteria and fungi from hard-to-heal wounds to the surface of DACC-coated dressings.

Subjects suffering from hard-to-heal wounds who are due to start using a dressing from the Sorbact range will be recruited at one investigation site in Sweden. The subjects will be divided into three groups by dressing type and there will be 10 subjects in each group, i.e., 10 subjects will be treated with Sorbact® Compress, 10 subjects will be treated with Sorbact® Gel Dressing, and 10 subjects will be treated with Sorbact® Ribbon Gauze. The dressings will be used in accordance with their respective IFU.

The clinical investigation is designed to have a treatment period of 14 days with no additional follow-up.

Three visits are planned for each subject, including a screening/baseline visit at the clinic and two further visits to the study clinic.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 systemic or topical antibiotic for the past two weeks or planning to use while participating in investigation.
4. Use of antimicrobial agent (e.g., silver- or iodine-containing dressings, or gels) during the last wo weeks
5. Use of a dressing from the Sorbact® range during the last two weeks
6. Subjects with any other condition that as judged by the investigator may make investigation procedures inappropriate

Trial design

Primary purpose: Basic Science

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 3 patient groups

Sorbact® Compress

Other group

Description:

Patients already assigned to start treatment with Sorbact® Compress as it is judged by the investigator to be the most suitable for their wounds

Treatment:

Device: Sorbact® Compress

Sorbact® Gel Dressing

Other group

Description:

Patients already assigned to start treatment with Sorbact® Gel Dressing as it is judged by the investigator to be the most suitable for their wounds

Treatment:

Device: Sorbact® Gel Dressing

Sorbact® Ribbon Gauze

Other group

Description:

Patients already assigned to start treatment with Sorbact® Ribbon Gauze as it is judged by the investigator to be the most suitable for their wounds

Treatment:

Device: Sorbact® Ribbon Gauze