Hard-to-heal WoundsNCT05089890
Clinical Investigation of Sorbact® Dressings
A study testing Sorbact® Compress, Sorbact® Gel Dressing and Sorbact® Ribbon Gauze in people with Hard-to-heal Wounds and Diabetic Foot Ulcer, run by ABIGO Medical AB at 1 site in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hard-to-heal Wounds, Diabetic Foot Ulcer, Venous Leg Ulcer
- What is being tested?
- Sorbact® Compress, Sorbact® Gel Dressing and Sorbact® Ribbon Gauze
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSweden
- Study dates
- 5 Apr 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Participating in another clinical investigation
- Known allergy or sensitivity to any components of the allocated investigational device
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sweden1 site, 1 recruiting
- Recruiting
Sahlgrenska University Hospital
Mölndal, 43143
Anders Jönsson, +46761361512, fana.hunegnaw@essity.com
About this study
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
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.
Read the 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
- Being tested
- Sorbact® Compress, Sorbact® Gel Dressing, Sorbact® Ribbon Gauze
- Medical subject headings
- Diabetic Foot, Varicose Ulcer, Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sorbact® CompressDevice
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 DressingDevice
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 GauzeDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Device: Sorbact® Ribbon Gauze |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 days (+1 day)
Secondary outcomes (3)
Wound bed microbial load at 14 days (±1 days) compared to baseline
qPCR (quantitiative polymerase chain reaction) will be used.
Measured: 14 days (±1 days)
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.
Measured: 14 days (±1 days)
Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline
PEA (proximity extension assay) will be used.
Measured: 14 days (±1 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start5 Apr 2025
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hard-to-heal WoundsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ABIGO Medical AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Anders Jönsson, MD, Principal investigator, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089890
- Sponsor's protocol ID
- DHF-5474
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2021
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05089890
- Acronym / sponsor ID
- DHF-5474
- Conditions
- Hard-to-heal Wounds, Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Arterial Leg Ulcer
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- ABIGO Medical ABIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2025 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 22 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Sorbact® Compress | Other | Device: Sorbact® CompressPatients already assigned to start treatment with Sorbact® Compress as it is judged by the investigator to be the most suitable for their wounds |
| Sorbact® Gel Dressing | Other | Device: Sorbact® Gel DressingPatients already assigned to start treatment with Sorbact® Gel Dressing as it is judged by the investigator to be the most suitable for their wounds |
| Sorbact® Ribbon Gauze | Other | Device: Sorbact® Ribbon GauzePatients already assigned to start treatment with Sorbact® Ribbon Gauze as it is judged by the investigator to be the most suitable for their wounds |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Participating in another clinical investigation
- Known allergy or sensitivity to any components of the allocated investigational device
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sorbact® CompressSorbact® 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® Compress |
| Sorbact® Gel DressingSorbact® 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® Gel Dressing |
| Sorbact® Ribbon GauzeSorbact® 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. | Device | Sorbact® Ribbon Gauze |
Primary outcome
Bacterial and fungal species irreversibly bound to the dressing after 2 days (+ 1 day).
Time frame: 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
3 secondary outcomes
Wound bed microbial load at 14 days (±1 days) compared to baseline
Time frame: 14 days (±1 days)
Wound bed bacteria and fungi species at baseline and at 14 days (±1 days)
Time frame: 14 days (±1 days)
Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline
Time frame: 14 days (±1 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Anders Jönsson, MD principal investigator
Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sorbact® Compress, Sorbact® Gel Dressing and Sorbact® Ribbon Gauze in people with Hard-to-heal Wounds and Diabetic Foot Ulcer, run by ABIGO Medical AB at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fana Hunegnaw (+46761361512, fana.hunegnaw@essity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial and fungal species irreversibly bound to the dressing after 2 days (+ 1 day). (time frame: 2 days (+1 day)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.