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Clinical Investigation of Sorbact® Dressings

Primary Purpose

Hard-to-heal Wounds, Diabetic Foot Ulcer, Venous Leg Ulcer

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Sorbact® Compress

Sorbact® Gel Dressing

Sorbact® Ribbon Gauze

About this trial

This is an interventional basic science trial for Hard-to-heal Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Arm Label

Sorbact® Compress

Sorbact® Gel Dressing

Sorbact® Ribbon Gauze

Arm Description

Patients already assigned to start treatment with Sorbact® Compress as it is judged by the investigator to be the most suitable for their wounds

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Wound bed microbial load at 14 days (±1 days) compared to baseline

qPCR (quantitiative polymerase chain reaction) will be used.

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.

Presence of endotoxin on the dressing after 2 days (+ 1 day)

LAL (Limulus amoebocyt lysat) method will be used.

Wound fluid endotoxin level at 14 days (±1 days) compared to baseline

LAL (Limulus amoebocyt lysat) method will be used.

Presence of inflammatory biomarkers on the dressing after 2 days (+ 1 day)

PEA (proximity extension assay) will be used.

Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline

PEA (proximity extension assay) will be used.

Full Information

NCT ID

NCT05089890

First Posted

September 30, 2021

Last Updated

October 20, 2021

Sponsor

ABIGO Medical AB

1. Study Identification

Unique Protocol Identification Number

NCT05089890

Brief Title

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 2021 (Anticipated)

Primary Completion Date

February 28, 2022 (Anticipated)

Study Completion Date

February 28, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

ABIGO Medical AB

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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)

Allocation

Non-Randomized

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Sorbact® Compress

Arm Type

Other

Arm Description

Patients already assigned to start treatment with Sorbact® Compress as it is judged by the investigator to be the most suitable for their wounds

Arm Title

Sorbact® Gel Dressing

Arm Type

Other

Arm Description

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

Arm Title

Sorbact® Ribbon Gauze

Arm Type

Other

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Sorbact® Compress

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sorbact® Gel Dressing

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Sorbact® Ribbon Gauze

Intervention Description

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.

Primary Outcome Measure Information:

Title

Bacterial and fungal species irreversibly bound to the dressing after 2 days (+ 1 day).

Description

Time Frame

2 days (+1 day)

Secondary Outcome Measure Information:

Title

Wound bed microbial load at 14 days (±1 days) compared to baseline

Description

qPCR (quantitiative polymerase chain reaction) will be used.

Time Frame

14 days (±1 days)

Title

Wound bed bacteria and fungi species at baseline and at 14 days (±1 days)

Description

16S rRNA and Internal Transcribed Spacer (ITS) sequencing will be used.

Time Frame

14 days (±1 days)

Title

Presence of endotoxin on the dressing after 2 days (+ 1 day)

Description

LAL (Limulus amoebocyt lysat) method will be used.

Time Frame

2 days (+ 1 day)

Title

Wound fluid endotoxin level at 14 days (±1 days) compared to baseline

Description

LAL (Limulus amoebocyt lysat) method will be used.

Time Frame

14 days (±1 days)

Title

Presence of inflammatory biomarkers on the dressing after 2 days (+ 1 day)

Description

PEA (proximity extension assay) will be used.

Time Frame

2 days (+ 1 day)

Title

Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline

Description

PEA (proximity extension assay) will be used.

Time Frame

14 days (±1 days)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Fana Hunegnaw

Phone

+46761361512

fana.hunegnaw@abigo.com

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Anders Jönsson, MD

Organizational Affiliation

Sahlgrenska University Hospital, Sweden

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Clinical Investigation of Sorbact® Dressings

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