Clinical Investigation of Sorbact® Dressings

NCT05089890 | Unknown

• 1 other identifier: DHF-5474
• Study Type: interventional
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

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

  14 days (±1 days)

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

  14 days (±1 days)

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

  2 days (+ 1 day)

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

  14 days (±1 days)

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

  2 days (+ 1 day)

Study Arms (3)

Sorbact® Compress

OTHER

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® Gel Dressing

OTHER

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® Ribbon Gauze

OTHER

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

Interventions

Sorbact® Compress DEVICE

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® Compress

Sorbact® Gel Dressing DEVICE

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® Gel Dressing

Sorbact® Ribbon Gauze DEVICE

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.

Sorbact® Ribbon Gauze

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ABIGO Medical AB: lead

MeSH Terms

Conditions

Diabetic Foot; Varicose Ulcer; Pressure Ulcer

Condition Hierarchy (Ancestors)

Diabetic Angiopathies; Vascular Diseases; Cardiovascular Diseases; Foot Ulcer; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies; Varicose Veins

Study Officials

• Anders Jönsson, MD

  Sahlgrenska University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fana Hunegnaw

CONTACT

+46761361512; fana.hunegnaw@abigo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: September 30, 2021
• First Posted: October 22, 2021
• Study Start: October 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share