Clinical Investigation of Sorbact® Dressings

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hard-to-heal Wounds; Diabetic Foot Ulcer; Venous Leg Ulcer; Pressure Ulcer; Arterial Leg Ulcer
• Intervention / Treatment: Device: Sorbact® Compress; Device: Sorbact® Gel Dressing; Device: Sorbact® Ribbon Gauze

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fana Hunegnaw; Phone Number: +46761361512; Email: fana.hunegnaw@abigo.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: NON_RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: 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	Device: 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.
OTHER: 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	Device: 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.
OTHER: 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	Device: 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: ABIGO Medical AB
• Investigators: Principal Investigator: Anders Jönsson, MD, Sahlgrenska University Hospital, Sweden

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): October 1, 2021
• Primary Completion (ANTICIPATED): February 28, 2022
• Study Completion (ANTICIPATED): February 28, 2022

Study Registration Dates

• First Submitted: September 30, 2021
• First Submitted That Met QC Criteria: October 20, 2021
• First Posted (ACTUAL): October 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Leg Ulcer; Varicose Ulcer; Pressure Ulcer
• Other Study ID Numbers: DHF-5474

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No