Clinical Investigation of Sorbact® Dressings

Not Applicable

• Conditions: Hard-to-heal Wounds; Diabetic Foot Ulcer; Pressure Ulcer; Arterial Leg Ulcer; Venous Leg Ulcer
• Interventions: Device: Sorbact® Gel Dressing; Device: Sorbact® Compress; Device: Sorbact® Ribbon Gauze

• Registration Number: NCT05089890
• Lead Sponsor: ABIGO Medical AB

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.

Study Timeline

• Study First Submitted: 2021-09-30
• Status Verified: 2021-10
• Study Start: 2021-10
• Study First Submitted QC: 2021-10-20
• Last Update Submitted: 2021-10-20
• Study First Posted: 2021-10-22
• Last Update Posted: 2021-10-22
• Primary Completion: 2022-02-28
• Study Completion: 2022-02-28

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
Wound fluid endotoxin level at 14 days (±1 days) compared to baseline	14 days (±1 days)	LAL (Limulus amoebocyt lysat) method will be used.
Presence of endotoxin on the dressing after 2 days (+ 1 day)	2 days (+ 1 day)	LAL (Limulus amoebocyt lysat) method will be used.
Presence of inflammatory biomarkers on the dressing after 2 days (+ 1 day)	2 days (+ 1 day)	PEA (proximity extension assay) will be used.