Arterial Leg Ulcer, Diabetic Foot Ulcer, Hard-to-heal Wounds, Pressure Ulcer, Venous Leg Ulcer
Conditions
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.
Interventions
DEVICESorbact® 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.
DEVICESorbact® 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.
DEVICESorbact® 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.
Sponsors
ABIGO Medical AB
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Wound bed microbial load at 14 days (±1 days) compared to baseline | 14 days (±1 days) | qPCR (quantitiative polymerase chain reaction) will be used. |
| Wound bed bacteria and fungi species at baseline and at 14 days (±1 days) | 14 days (±1 days) | 16S rRNA and Internal Transcribed Spacer (ITS) sequencing will be used. |
| Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline | 14 days (±1 days) | PEA (proximity extension assay) will be used. |
Countries
Sweden
Contacts
CONTACTFana Hunegnaw
PRINCIPAL_INVESTIGATORAnders Jönsson, MD
Sahlgrenska University Hospital
Outcome results
None listed