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A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions (ASOLO-SCI)

Primary Purpose

Incision, Surgical, Surgical Incision, Surgical Wound

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Avance® Solo NPWT System
Sponsored by
Molnlycke Health Care AB
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Incision, Surgical focused on measuring Negative Pressure Wound Therapy, Post Market Clinical Follow-up, Vacuum Assisted Closure

Eligibility Criteria

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

Inclusion criteria:

  1. Male or female ≥ 18 years of age.
  2. Signed written Informed Consent Form.
  3. Low to moderate exuding surgically closed incisions suitable for suNPWT, according with the Investigator´s judgement and the Avance® Solo NPWT System Instructions for Use.
  4. Study subjects that are deemed capable and willing to comply with the protocol instructions.

Exclusion criteria:

  1. Known malignancy in the wound or margins of the wound.
  2. Untreated and previously confirmed osteomyelitis.
  3. Non-enteric and unexplored fistulas.
  4. Necrotic tissue with eschar present.
  5. Exposed nerves, arteries, veins or organs.
  6. Exposed anastomotic site.
  7. Known allergy/hypersensitivity to the dressing or its components.
  8. Known pregnancy or planning to become pregnant or breastfeeding at time of study participation.
  9. Participation in another investigative drug or device trial currently or within the last 30 days.
  10. Subjects not suitable for the investigation according to the Investigator's judgement, Clinical Investigation Plan and Instructions for Use.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Experimental

    Arm Label

    Subjects with a low to moderate exuding surgically closed incision

    Arm Description

    Up to 34 study Subjects with a low to moderate exuding surgically closed incision deemed adequate by the Principal Investigator and clinical team for NPWT treatment.

    Outcomes

    Primary Outcome Measures

    Change in wound remaining closed
    The evaluation of the wound remaining closed is captured through an assessment by the Principal Investigator/clinical team from baseline to the final visit (wound remaining closed yes/no).

    Secondary Outcome Measures

    Wound progress to baseline
    Wound progress in low to moderate surgically closed incisions compared between baseline and final visit (deteriorated/no change/improved).
    Change in wound progress across visits
    Wound progress in low to moderate surgically closed incisions compared to last visit (deteriorated/no change/improved).
    Change in lack of dermal opposition
    Lack of dermal opposition as a percentage of the total wound length from baseline to all follow-up visits.
    Change in exudate amount
    Change in exudate amount from baseline to all follow-up visits (none/low/moderate/high).
    Change in exudate nature
    Change in exudate nature from baseline to all follow-up visits (serous/fibrinous/serosanguinous/sanguineous/seropurulent/purulent/foul purulent//haemopurulent/haemorrhagic).
    Change in exudate odour
    Change in exudate odour from baseline to all follow-up visits (no odour/slight/moderate/strong/very strong).
    Change in peri-wound conditions
    Change in peri-wound skin condition from baseline to all follow-up visits (normal/erythematous/oedematous/eczematous/excoriated/macerated/indurated).
    Pain assessment
    Subject evaluation of pain at Avance® Solo Border Dressing and Avance® Solo Fixation Strips removal using a Numeric Rating Scale at each follow-up visit (where the Subject verbally grade their pain on a level from 0 to 10, where 0 indicates no pain and 10 the worst imaginable for the Subject; the NRS will be used before and during dressing removal).
    Absorption and transportation of exudate
    Clinical assessment of Avance® Solo NPWT System's ability to absorb and/or transport exudate using a rating scale at all follow-up visits (very poor/poor/good/very good).
    Trauma to the wound's surrounding skin
    Proportion of Subjects with trauma (e.g. blistering) to the wound site and surrounding skin for Avance® Solo Border Dressing and Avance® Solo Fixation Strips at all follow-up visits.
    System wear time
    Evaluate system wear time in days from baseline to all follow-up visits including potential extra visits.
    Sounding of alarms
    Subject evaluation of the system properties (number of sounding alarms) assessed at all follow-up visits (souding of alarms in the following intervals 0, 1-5, 6-10, 11-15, 16-20, more than 20).
    Product consumption
    Product consumption of the utilised products for the system, from baseline to final visit using the Avance® Solo NPWT System (in total number of Avance® Solo Pumps, Border Dressing, Canisters, Fixation Strips, and batteries).
    Subject quality of life assessment
    Subject evaluation of the Avance® Solo NPWT system impact of everyday life at day 14 or final visit. Quality of life is assessed using Numeric Rating Scale (NRS) where the Subject grades how much the treatment has affected their daily life. 0 is equal to no influence, and 10 is equal to considerable influence on everyday life or unbearable. If replying >0, the Subject shall state the presence or absence of the following causes: leakage of dressing, impaired mobility, difficulties in getting dressed, pain, and odour.
    Ease of application and removal of the Avance® Solo NPWT System
    Clinician evaluation of ease of application and removal of the Avance® Solo NPWT System using a Numeric Rating Scale collected at baseline and each follow-up visit (from 0 to 10, wherein 0 is equal to no problem with application or removal, and 10 is the worst imaginable situation when applying/removing the system from a Subject).
    Subject compliance
    Evaluate the Subject compliance to Avance® Solo NPWT System therapy at all follow-up visits by the average number of hours per day that the system has not provided NPWT since the Subject's last visit.
    Global satisfaction
    Evaluation of the Principal Investigator and Subject's global satisfactions with the system at day 14 or final visit (very dissatisfied/dissatisfied/neither dissatisfied or satisfied/satisfied/very satisfied).

    Full Information

    First Posted
    May 10, 2021
    Last Updated
    May 17, 2021
    Sponsor
    Molnlycke Health Care AB
    Collaborators
    Syntactx
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04894604
    Brief Title
    A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions
    Acronym
    ASOLO-SCI
    Official Title
    A Prospective, Open, Non-comparative, Post-Market Clinical Follow-up Investigation to Confirm the Safety and Performance of Avance® Solo NPWT System in Surgically Closed Incisions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2021
    Overall Recruitment Status
    Unknown status
    Study Start Date
    June 30, 2021 (Anticipated)
    Primary Completion Date
    February 28, 2022 (Anticipated)
    Study Completion Date
    March 31, 2022 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Molnlycke Health Care AB
    Collaborators
    Syntactx

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the Instructions for Use (IfU).
    Detailed Description
    The ASOLO-SCI investigation is designed as a prospective, open, non-comparative, PMCF study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the IfU in up to 34 patients (n=34). The ASOLO-SCI investigation is a multicentre study that is expected to take place in approximately three European centres. The study treatment shall be stopped earlier (i.e. prior to 14 days), in the event study Subjects withdraw their consent, or shall the Principal Investigator and clinical team deem the Avance® Solo NPWT System to be no longer adequate for the study Subject's wound. Following termination of Subject participation for whichever reason in the study, the patient shall be followed in accordance with the local standard of care in wound management and treatment. As a primary endpoint, the Principal Investigator and clinical team will evaluate whether the surgical incision remains closed, from baseline to study end at Day 14.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Incision, Surgical, Surgical Incision, Surgical Wound, Surgical Wound, Recent, Surgical Wound Dehiscence
    Keywords
    Negative Pressure Wound Therapy, Post Market Clinical Follow-up, Vacuum Assisted Closure

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Model Description
    Single group of Subjects (with a low to moderate exuding surgically closed incision) in use of the Avance® Solo NPWT System.
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Subjects with a low to moderate exuding surgically closed incision
    Arm Type
    Experimental
    Arm Description
    Up to 34 study Subjects with a low to moderate exuding surgically closed incision deemed adequate by the Principal Investigator and clinical team for NPWT treatment.
    Intervention Type
    Device
    Intervention Name(s)
    Avance® Solo NPWT System
    Intervention Description
    Application of the Avance® Solo NPWT System on up to 34 study Subjects, in accordance with the IfU for up to 14 days.
    Primary Outcome Measure Information:
    Title
    Change in wound remaining closed
    Description
    The evaluation of the wound remaining closed is captured through an assessment by the Principal Investigator/clinical team from baseline to the final visit (wound remaining closed yes/no).
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Secondary Outcome Measure Information:
    Title
    Wound progress to baseline
    Description
    Wound progress in low to moderate surgically closed incisions compared between baseline and final visit (deteriorated/no change/improved).
    Time Frame
    Day 14 (+0/-2 days)
    Title
    Change in wound progress across visits
    Description
    Wound progress in low to moderate surgically closed incisions compared to last visit (deteriorated/no change/improved).
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Change in lack of dermal opposition
    Description
    Lack of dermal opposition as a percentage of the total wound length from baseline to all follow-up visits.
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Change in exudate amount
    Description
    Change in exudate amount from baseline to all follow-up visits (none/low/moderate/high).
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Change in exudate nature
    Description
    Change in exudate nature from baseline to all follow-up visits (serous/fibrinous/serosanguinous/sanguineous/seropurulent/purulent/foul purulent//haemopurulent/haemorrhagic).
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Change in exudate odour
    Description
    Change in exudate odour from baseline to all follow-up visits (no odour/slight/moderate/strong/very strong).
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Change in peri-wound conditions
    Description
    Change in peri-wound skin condition from baseline to all follow-up visits (normal/erythematous/oedematous/eczematous/excoriated/macerated/indurated).
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Pain assessment
    Description
    Subject evaluation of pain at Avance® Solo Border Dressing and Avance® Solo Fixation Strips removal using a Numeric Rating Scale at each follow-up visit (where the Subject verbally grade their pain on a level from 0 to 10, where 0 indicates no pain and 10 the worst imaginable for the Subject; the NRS will be used before and during dressing removal).
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Absorption and transportation of exudate
    Description
    Clinical assessment of Avance® Solo NPWT System's ability to absorb and/or transport exudate using a rating scale at all follow-up visits (very poor/poor/good/very good).
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Trauma to the wound's surrounding skin
    Description
    Proportion of Subjects with trauma (e.g. blistering) to the wound site and surrounding skin for Avance® Solo Border Dressing and Avance® Solo Fixation Strips at all follow-up visits.
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    System wear time
    Description
    Evaluate system wear time in days from baseline to all follow-up visits including potential extra visits.
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Sounding of alarms
    Description
    Subject evaluation of the system properties (number of sounding alarms) assessed at all follow-up visits (souding of alarms in the following intervals 0, 1-5, 6-10, 11-15, 16-20, more than 20).
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Product consumption
    Description
    Product consumption of the utilised products for the system, from baseline to final visit using the Avance® Solo NPWT System (in total number of Avance® Solo Pumps, Border Dressing, Canisters, Fixation Strips, and batteries).
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Subject quality of life assessment
    Description
    Subject evaluation of the Avance® Solo NPWT system impact of everyday life at day 14 or final visit. Quality of life is assessed using Numeric Rating Scale (NRS) where the Subject grades how much the treatment has affected their daily life. 0 is equal to no influence, and 10 is equal to considerable influence on everyday life or unbearable. If replying >0, the Subject shall state the presence or absence of the following causes: leakage of dressing, impaired mobility, difficulties in getting dressed, pain, and odour.
    Time Frame
    Day 14 (+0/-2 days)
    Title
    Ease of application and removal of the Avance® Solo NPWT System
    Description
    Clinician evaluation of ease of application and removal of the Avance® Solo NPWT System using a Numeric Rating Scale collected at baseline and each follow-up visit (from 0 to 10, wherein 0 is equal to no problem with application or removal, and 10 is the worst imaginable situation when applying/removing the system from a Subject).
    Time Frame
    Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Subject compliance
    Description
    Evaluate the Subject compliance to Avance® Solo NPWT System therapy at all follow-up visits by the average number of hours per day that the system has not provided NPWT since the Subject's last visit.
    Time Frame
    Day 7 (+0/-2 days), Day 14 (+0/-2 days)
    Title
    Global satisfaction
    Description
    Evaluation of the Principal Investigator and Subject's global satisfactions with the system at day 14 or final visit (very dissatisfied/dissatisfied/neither dissatisfied or satisfied/satisfied/very satisfied).
    Time Frame
    Day 14 (+0/-2 days)

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion criteria: Male or female ≥ 18 years of age. Signed written Informed Consent Form. Low to moderate exuding surgically closed incisions suitable for suNPWT, according with the Investigator´s judgement and the Avance® Solo NPWT System Instructions for Use. Study subjects that are deemed capable and willing to comply with the protocol instructions. Exclusion criteria: Known malignancy in the wound or margins of the wound. Untreated and previously confirmed osteomyelitis. Non-enteric and unexplored fistulas. Necrotic tissue with eschar present. Exposed nerves, arteries, veins or organs. Exposed anastomotic site. Known allergy/hypersensitivity to the dressing or its components. Known pregnancy or planning to become pregnant or breastfeeding at time of study participation. Participation in another investigative drug or device trial currently or within the last 30 days. Subjects not suitable for the investigation according to the Investigator's judgement, Clinical Investigation Plan and Instructions for Use.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Alexandre Welikow, MD
    Phone
    0046317223045
    Email
    alexandre.welikow@molnlycke.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Tahmina Haider, MSc
    Phone
    0046739503674
    Email
    tahmina.haider@molnlycke.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions

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