Clinical Investigation of Sorbact® Dressings
Primary Purpose
Hard-to-heal Wounds, Diabetic Foot Ulcer, Venous Leg Ulcer
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Sorbact® Compress
Sorbact® Gel Dressing
Sorbact® Ribbon Gauze
Sponsored by
About this trial
This is an interventional basic science trial for Hard-to-heal Wounds
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Participating in another clinical investigation
- Known allergy or sensitivity to any components of the allocated investigational device
- Use of systemic or topical antibiotic for the past two weeks or planning to use while participating in investigation.
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Other
Other
Other
Arm Label
Sorbact® Compress
Sorbact® Gel Dressing
Sorbact® Ribbon Gauze
Arm Description
Patients already assigned to start treatment with Sorbact® Compress as it is judged by the investigator to be the most suitable for their wounds
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
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
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Wound bed microbial load at 14 days (±1 days) compared to baseline
qPCR (quantitiative polymerase chain reaction) will be used.
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.
Presence of endotoxin on the dressing after 2 days (+ 1 day)
LAL (Limulus amoebocyt lysat) method will be used.
Wound fluid endotoxin level at 14 days (±1 days) compared to baseline
LAL (Limulus amoebocyt lysat) method will be used.
Presence of inflammatory biomarkers on the dressing after 2 days (+ 1 day)
PEA (proximity extension assay) will be used.
Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline
PEA (proximity extension assay) will be used.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05089890
Brief Title
Clinical Investigation of Sorbact® Dressings
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
October 2021 (Anticipated)
Primary Completion Date
February 28, 2022 (Anticipated)
Study Completion Date
February 28, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ABIGO Medical AB
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hard-to-heal Wounds, Diabetic Foot Ulcer, Venous Leg Ulcer, Pressure Ulcer, Arterial Leg Ulcer
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sorbact® Compress
Arm Type
Other
Arm Description
Patients already assigned to start treatment with Sorbact® Compress as it is judged by the investigator to be the most suitable for their wounds
Arm Title
Sorbact® Gel Dressing
Arm Type
Other
Arm Description
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
Arm Title
Sorbact® Ribbon Gauze
Arm Type
Other
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Sorbact® Compress
Intervention Description
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
Intervention Name(s)
Sorbact® Gel Dressing
Intervention Description
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
Intervention Name(s)
Sorbact® Ribbon Gauze
Intervention Description
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.
Primary Outcome Measure Information:
Title
Bacterial and fungal species irreversibly bound to the dressing after 2 days (+ 1 day).
Description
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 Outcome Measure Information:
Title
Wound bed microbial load at 14 days (±1 days) compared to baseline
Description
qPCR (quantitiative polymerase chain reaction) will be used.
Time Frame
14 days (±1 days)
Title
Wound bed bacteria and fungi species at baseline and at 14 days (±1 days)
Description
16S rRNA and Internal Transcribed Spacer (ITS) sequencing will be used.
Time Frame
14 days (±1 days)
Title
Presence of endotoxin on the dressing after 2 days (+ 1 day)
Description
LAL (Limulus amoebocyt lysat) method will be used.
Time Frame
2 days (+ 1 day)
Title
Wound fluid endotoxin level at 14 days (±1 days) compared to baseline
Description
LAL (Limulus amoebocyt lysat) method will be used.
Time Frame
14 days (±1 days)
Title
Presence of inflammatory biomarkers on the dressing after 2 days (+ 1 day)
Description
PEA (proximity extension assay) will be used.
Time Frame
2 days (+ 1 day)
Title
Wound fluid inflammatory biomarker levels at 14 days (±1 days) compared to baseline
Description
PEA (proximity extension assay) will be used.
Time Frame
14 days (±1 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Participating in another clinical investigation
Known allergy or sensitivity to any components of the allocated investigational device
Use of systemic or topical antibiotic for the past two weeks or planning to use while participating in investigation.
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fana Hunegnaw
Phone
+46761361512
Email
fana.hunegnaw@abigo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anders Jönsson, MD
Organizational Affiliation
Sahlgrenska University Hospital, Sweden
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Investigation of Sorbact® Dressings
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