Clinical trial NCT05089890: Clinical Investigation of Sorbact® Dressings
Official title: An Open, Single-centre, Clinical Investigation to Explore the Binding of Bacteria and Fungi to Dialkylcarbamoyl Chloride (DACC)-Coated Dressings From Hard-to-heal Wounds
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hard-to-heal Wounds
Diabetic Foot Ulcer
Venous Leg Ulcer
Pressure Ulcer
Arterial Leg Ulcer
Lead sponsor: ABIGO Medical AB
Sponsor class: INDUSTRY
First posted: 2021-10-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be divided in 3 cohorts and will be treated with 3 different devices. The choice of which dressing to use depends of the characters of the wounds.
Primary purpose: BASIC_SCIENCE

Brief 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.

Detailed 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.

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 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

Primary outcomes:
measure: Bacterial and fungal species irreversibly bound to the dressing after 2 days (+ 1 day).
timeFrame: 2 days (+1 day)
Secondary outcomes:
measure: Wound bed microbial load at 14 days (±1 days) compared to baseline
timeFrame: 14 days (±1 days)
measure: Wound bed bacteria and fungi species at baseline and at 14 days (±1 days)
timeFrame: 14 days (±1 days)
measure: Presence of endotoxin on the dressing after 2 days (+ 1 day)
timeFrame: 2 days (+ 1 day)
measure: Wound fluid endotoxin level at 14 days (±1 days) compared to baseline
timeFrame: 14 days (±1 days)
measure: Presence of inflammatory biomarkers on the dressing after 2 days (+ 1 day)
timeFrame: 2 days (+ 1 day)
measure: Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline
timeFrame: 14 days (±1 days)
Other outcomes:
Locations:
Study officials:
affiliation: Sahlgrenska University Hospital
name: Anders Jönsson, MD
role: PRINCIPAL_INVESTIGATOR
References: