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Clinical Investigation of Sorbact® Dressings

NCT ID: NCT05089890

Last Updated: 2021-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-31

Study Completion Date

2022-02-28

Brief Summary

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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

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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

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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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

Group Type OTHER

Sorbact® Compress

Intervention Type 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® 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

Group Type OTHER

Sorbact® Gel Dressing

Intervention Type 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® 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

Group Type OTHER

Sorbact® Ribbon Gauze

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ABIGO Medical AB

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anders Jönsson, MD

Role: PRINCIPAL_INVESTIGATOR

Sahlgrenska University Hospital

Central Contacts

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Fana Hunegnaw

Role: CONTACT

[email protected]
+46761361512

Other Identifiers

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DHF-5474

Identifier Type: -

Identifier Source: org_study_id