Clinical Investigation of Sorbact® Dressings
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorABIGO Medical AB
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Sorbact® Compress
DeviceSorbact® 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
DeviceSorbact® 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
DeviceSorbact® 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.
Treatment groups
30 Participants
are divided into 3 treatment groupsGroup A: Sorbact® CompressOther 1 intervention
Group B: Sorbact® Gel DressingOther 1 intervention
Group C: Sorbact® Ribbon GauzeOther 1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)2
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)3
Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline
PEA (proximity extension assay) will be used.
Time frame
14 days (±1 days)Sponsors and contacts
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Source ClinicalTrials.gov