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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
ABIGO Medical AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hard-to-heal Wounds

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Able to read and understand the Subject Information and Informed Consent Form and provide meaningful informed consent
  2. Due to start using one of the following dressings: Sorbact® Compress, Sorbact® Gel Dressing and Sorbact® Ribbon Gauze
  3. Age ≥18 years
  4. 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:

  1. Participating in another clinical investigation
  2. Known allergy or sensitivity to any components of the allocated investigational device
  3. Use of systemic or topical antibiotic for the past two weeks or planning to use while participating in investigation.
  4. Use of antimicrobial agent (e.g., silver- or iodine-containing dressings, or gels) during the last wo weeks
  5. Use of a dressing from the Sorbact® range during the last two weeks
  6. 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

    First Posted
    September 30, 2021
    Last Updated
    October 20, 2021
    Sponsor
    ABIGO Medical AB
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    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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