NCT05089890

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: ABIGO Medical AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
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.
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.
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.

Timeline

• Start date: 2021-10-01
• Primary completion: 2022-02-28
• Completion: 2022-02-28
• First posted: 2021-10-22
• Last updated: 2021-10-22