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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
30
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® 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.
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
Time frame: 2 days (+1 day)
Wound bed microbial load at 14 days (±1 days) compared to baseline
qPCR (quantitiative polymerase chain reaction) will be used.
Time frame: 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.
Time frame: 14 days (±1 days)
Presence of endotoxin on the dressing after 2 days (+ 1 day)
LAL (Limulus amoebocyt lysat) method will be used.
Time frame: 2 days (+ 1 day)
Wound fluid endotoxin level at 14 days (±1 days) compared to baseline
LAL (Limulus amoebocyt lysat) method will be used.
Time frame: 14 days (±1 days)
Presence of inflammatory biomarkers on the dressing after 2 days (+ 1 day)
PEA (proximity extension assay) will be used.
Time frame: 2 days (+ 1 day)
Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline
PEA (proximity extension assay) will be used.
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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.
Time frame: 14 days (±1 days)