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Clinical Trials in Sweden / NCT05089890
Recruiting Not applicable

Clinical Investigation of Sorbact® Dressings

NCT05089890 · tracked via the Priya Life Science Sweden tracker
Sponsor
ABIGO Medical AB
Phase
Not applicable
Started
2025-04-05
Last updated
2026-09-14

Condition(s) studied

Hard-to-heal WoundsDiabetic Foot UlcerVenous Leg UlcerPressure UlcerArterial Leg Ulcer

Investigational drug(s) / intervention(s)

Sorbact® CompressSorbact® Gel DressingSorbact® Ribbon Gauze

Sorbact® Compress: Sorbact® technology is a bacteria- and fungi-binding wound contact layer from which Sorbact® Compress has been developed. The patients will be in one of these 3 arms depending on the choice of dressing most suitable for their wounds. The purpose of the study is not to compare between the devices, but to study each device on its own.

Sorbact® Gel Dressing: Sorbact® technology is a bacteria- and fungi-binding wound contact layer from which Sorbact® Gel Dressing has been developed. The patients will be in one of these 3 arms depending on the choice of dressing most suitable for their wounds. The purpose of the study is not to compare between the devices, but to study each device on its own.

Sorbact® Ribbon Gauze: Sorbact® technology is a bacteria- and fungi-binding wound contact layer from which Sorbact® Ribbon Gauze has been developed. The patients will be in one of these 3 arms depending on the choice of dressing most suitable for their wounds. The purpose of the study is not to compare between the devices, but to study each device on its own.

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Bacterial and fungal species irreversibly bound to the dressing after 2 days (+ 1 day). — 2 days (+1 day)
    The measurements that will be used to assess the primary outcome are 16S rRNA sequencing to identify bacterial species, Internal Transcribed Spacer (ITS) sequencing to identify fungal species and scanning electron microscopy (SEM) images for visualization of bacteria and fungi bound to the dressing

Trial sites (1)

FacilityCityRegionStatus
Sahlgrenska University Hospital Mölndal Sweden Recruiting

Other trials for the same condition

Combined Molecular and Mechanistic Methods for Detection of Pressure Ulcers Starting soon
Laser Photobiomodulation for Hard-to-heal Ulcers in Frail Older Adults Active, not recruiting
PROSENIOR. Prevention of Pressure Ulcers, Malnutrition, Poor Oral Health and Falls Among Older Persons Receiving Municipal Health Care and Are Registered in the Quality Registry Senior Alert Recruiting
Allogeneic ABCB5-positive Dermal Mesenchymal Stromal Cells for Treatment of Therapy-resistant CVU (Phase III) Active, not recruiting
Treating Diabetic Foot Ulcers, Comparing Two Topical Antimicrobial Agents, Dakin´s and Prontosan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05089890 on ClinicalTrials.gov ↗ ← All trials in Sweden