Clinical Investigation of Sorbact® Dressings

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

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

Intervention / Treatment
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* Device: Sorbact® Compress
* Device: Sorbact® Gel Dressing
* Device: Sorbact® Ribbon Gauze


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Sorbact® Compress<br>Patients already assigned to start treatment with Sorbact® Compress as it is judged by the investigator to be the most suitable for their wounds | Device: Sorbact® Compress<br>* 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.<br>|
| Other: Sorbact® Gel Dressing<br>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 | Device: Sorbact® Gel Dressing<br>* 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.<br>|
| Other: Sorbact® Ribbon Gauze<br>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 | Device: Sorbact® Ribbon Gauze<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial and fungal species irreversibly bound to the dressing after 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 | 2 days (+1 day) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound bed microbial load at 14 days (±1 days) compared to baseline | qPCR (quantitiative polymerase chain reaction) will be used. | 14 days (±1 days) | 
| Wound bed bacteria and fungi species at baseline and at 14 days (±1 days) | 16S rRNA and Internal Transcribed Spacer (ITS) sequencing will be used. | 14 days (±1 days) | 
| Presence of endotoxin on the dressing after 2 days (+ 1 day) | LAL (Limulus amoebocyt lysat) method will be used. | 2 days (+ 1 day) | 
| Wound fluid endotoxin level at 14 days (±1 days) compared to baseline | LAL (Limulus amoebocyt lysat) method will be used. | 14 days (±1 days) | 
| Presence of inflammatory biomarkers on the dressing after 2 days (+ 1 day) | PEA (proximity extension assay) will be used. | 2 days (+ 1 day) | 
| Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline | PEA (proximity extension assay) will be used. | 14 days (±1 days) |