Clinical Investigation of Sorbact® Dressings

Diabetic Foot Ulcer Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05089890
• Other study ID #: DHF-5474
• Status: Not yet recruiting
• Phase: N/A
• Start date: October 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: October 2021
• Source: ABIGO Medical AB
• Contact: Fana Hunegnaw
• Phone: +46761361512
• Email: fana.hunegnaw[@]abigo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

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.
• 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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
ABIGO Medical AB

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound bed microbial load at 14 days (±1 days) compared to baseline	qPCR (quantitiative polymerase chain reaction) will be used.	14 days (±1 days)
Secondary	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)
Secondary	Presence of endotoxin on the dressing after 2 days (+ 1 day)	LAL (Limulus amoebocyt lysat) method will be used.	2 days (+ 1 day)
Secondary	Wound fluid endotoxin level at 14 days (±1 days) compared to baseline	LAL (Limulus amoebocyt lysat) method will be used.	14 days (±1 days)
Secondary	Presence of inflammatory biomarkers on the dressing after 2 days (+ 1 day)	PEA (proximity extension assay) will be used.	2 days (+ 1 day)
Secondary	Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline	PEA (proximity extension assay) will be used.	14 days (±1 days)