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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Wound bed microbial load at 14 days (±1 days) compared to baseline | qPCR (quantitiative polymerase chain reaction) will be used. | 14 days (±1 days) |
| Wound bed bacteria and fungi species at baseline and at 14 days (±1 days) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Fana Hunegnaw | Contact | +46761361512 | fana.hunegnaw@abigo.com |
| Name | Affiliation | Role |
|---|---|---|
| Anders Jönsson, MD | Sahlgrenska University Hospital | Principal Investigator |
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| ID | Term |
|---|---|
| D017719 | Diabetic Foot |
| D014647 | Varicose Ulcer |
| D003668 | Pressure Ulcer |
| ID | Term |
|---|---|
| D003925 | Diabetic Angiopathies |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D016523 | Foot Ulcer |
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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.
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|
| 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® 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. |
|
16S rRNA and Internal Transcribed Spacer (ITS) sequencing will be used.
| 14 days (±1 days) |
| Presence of endotoxin on the dressing after 2 days (+ 1 day) | LAL (Limulus amoebocyt lysat) method will be used. | 2 days (+ 1 day) |
| Wound fluid endotoxin level at 14 days (±1 days) compared to baseline | LAL (Limulus amoebocyt lysat) method will be used. | 14 days (±1 days) |
| Presence of inflammatory biomarkers on the dressing after 2 days (+ 1 day) | PEA (proximity extension assay) will be used. | 2 days (+ 1 day) |
| Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline | PEA (proximity extension assay) will be used. | 14 days (±1 days) |
| D007871 |
| Leg Ulcer |
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D048909 | Diabetes Complications |
| D003920 | Diabetes Mellitus |
| D004700 | Endocrine System Diseases |
| D003929 | Diabetic Neuropathies |
| D014648 | Varicose Veins |