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Confirm the Safety and Performance of Avance Solo NPWT System (ASOLO-SW)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04754048
Recruitment Status : Recruiting
First Posted : February 15, 2021
Last Update Posted : July 12, 2021
Sponsor:
Collaborator:
Syntactx
Information provided by (Responsible Party):
Molnlycke Health Care AB

Brief Summary:
The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm safety and performance of Avance® Solo NPWT System in low to moderate exuding acute (traumatic wounds and flaps and grafts), as well as subacute (e.g., dehisced wounds) wounds when used in accordance with the Instructions for Use, for up to 28 days.

Condition or disease Intervention/treatment Phase
Acute Wound Traumatic Wound Skin Graft Skin Flap Subacute Wound Dehiscence Device: Avance Solo NPWT System Not Applicable

Detailed Description:

This investigation is designed as a prospective, open, non-comparative, PMCF investigation to confirm safety and performance of Avance Solo NPWT System in subjects with traumatic wounds (n=34), subacute (e.g., dehisced wounds) wounds (n=34), and flaps and grafts (n=34). This is a multi-center study that will take place in approximately 5 European countries. The eligible subjects will be both in and out patients and all will be treated with Avance Solo NPWT System, for up to 28 days.

Treatment will be stopped if the wound is considered healed, has a high enough percentage of graft take, or enough flap viability by the judgement of the clinicians before the complete treatment time (28 days).

The primary performance endpoint will include assessment of wound progress compared to last visit during a maximum 28 days investigation period. Wound progression is determined by the Investigator and will be assessed at each follow-up visit and measured by three outcomes:

  • Deteriorated
  • No change
  • Improved

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Intervention Model Description: Three different patient groups treated with the Avance Solo NPWT System
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm Safety and Performance of Avance Solo NPWT System in Low to Moderate Exuding Acute (Traumatic Wounds and Flaps and Grafts), as Well as Subacute (e.g., Dehisced Wounds) Wounds
Actual Study Start Date : June 15, 2021
Estimated Primary Completion Date : February 21, 2022
Estimated Study Completion Date : March 21, 2022

Resource links provided by the National Library of Medicine

Drug Information available for: Diazepam

Arm Intervention/treatment
Experimental: Traumatic wounds
Treatment with negative pressure wound therapy.
Device: Avance Solo NPWT System
Wound treatment with Avance Solo NPWT System for up to 28 days.

Experimental: Subacute wounds (e.g., dehisced wounds)
Treatment with negative pressure wound therapy.
Device: Avance Solo NPWT System
Wound treatment with Avance Solo NPWT System for up to 28 days.

Experimental: Flaps and Grafts
Treatment with negative pressure wound therapy.
Device: Avance Solo NPWT System
Wound treatment with Avance Solo NPWT System for up to 28 days.




Primary Outcome Measures :
  1. Change in wound progress [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]

    Wound progress compared to last visit and assessed as:

    • Deteriorated
    • No change
    • Improved


Secondary Outcome Measures :
  1. Wound progress [ Time Frame: 28 days ]

    Wound progress compared between baseline and final visit and assessed as:

    • Deteriorated
    • No change
    • Improved

  2. Wound dimension [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]
    Absolute and percentage change in wound area and volume from baseline to all follow-up visits.

  3. Tissue type [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]
    Change in tissue type (slough, necrotic, granulation or epithelization) from baseline to all follow-up visits.

  4. Exudate [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]

    Change in exudate amount, nature, and odor using a category scoring system from baseline to all follow-up visits.

    Amount: none, low, moderate, or high

    Nature: serous, fibrinous, serosanguineous, sanguineous, seropurulent, purulent, foul purulent, heamopurulent, or hemorrhagic

    Odor: No odor, slight, moderate, strong, very strong


  5. Peri-wound [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]

    Change in peri-wound skin condition from baseline to all follow-up visits using the following conditions:

    • Normal
    • Erythematous
    • Oedematous
    • Eczematous
    • Excoriated
    • Macerated
    • Indurated

  6. Pain assessment [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]
    Subject evaluation of pain at Avance Solo dressing removal using Numeric Rating Scale (NRS) at each follow-up visit.

  7. Absorb and transport of exudate [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]
    Clinician evaluation of Avance Solo NPWT System ability to absorb and transport exudate assessed at all follow-up visits

  8. Tissue in-growth [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) with additional assessments in between when dressing is changed ]
    Degree of tissue in-growth when Avance Solo foam is utilized at all follow-up visits as well as extra visits.

  9. Trauma [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]
    Proportion of subjects with trauma to the wound site and surrounding skin for Avance Solo Border Dressing and also Avance Solo fixation strips at all follow-up visits

  10. Graft take [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]
    Change in percentage of graft take and wound epithelization from baseline to all follow-up visits

  11. Flap survival [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]
    Change in percentage of flap survival from baseline to all follow-up visits

  12. Wear time [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]
    Evaluate Avance Solo NPWT System wear time in days from baseline to all follow-up visits including potential extra visits

  13. Alarms [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]

    Subject evaluation of the Avance Solo NPWT System properties (number of sounding alarms) assessed with a given scale at all follow-up visits

    • 0
    • 1-5
    • 6-10
    • 11-15
    • 16-20
    • More than 20

  14. Product consumption [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]
    Product consumption of the utilized products for the Avance Solo NPWT System, from baseline and final visit using the Avance Solo NPWT System

  15. Quality of life assessment [ Time Frame: 28 days ]
    Subject evaluation of the Avance Solo NPWT system impact of everyday life

  16. Ease of application [ Time Frame: Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]
    Clinician evaluation of ease of application and removal of the Avance Solo NPWT System using a Numeric Rating Scale (NRS) collected at baseline, and each follow-up visit.

  17. Compliance [ Time Frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) ]
    Evaluate the compliance to Avance Solo NPWT System therapy by average number of hours per 24h that the system has not provided treatment since last visit.

  18. Global satisfaction [ Time Frame: 28 days ]

    Evaluate the investigator and subject global satisfaction of the Avance Solo NPWT System in regards to:

    • Very dissatisfied
    • Dissatisfied
    • Neither satisfied or dissatisfied
    • Satisfied
    • Very satisfied



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female ≥ 18 years.
  2. Signed written informed consent.
  3. Low to moderate exuding acute (traumatic wound, or a flap/graft) or subacute (e.g., dehisced wounds) wounds suitable for single use NPWT according to the investigator´s judgement and Instructions for Use

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. Subjects with known allergies/hypersensitivity to product components.
  8. Known pregnancy or planning to become pregnant or lactation at the time of study participation.
  9. Subjects not suitable for the investigation according to the investigator's judgement and Clinical Investigation Plan and IFU.
  10. Participating in other ongoing clinical investigation, or during the past 30 days that may impact the outcome of this investigation based on the judgement of the investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04754048


Contacts
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Contact: Daniel Sundh, PhD 0046739412816 daniel.sundh@molnlycke.com
Contact: Tahmina Haider, MSc 0046739503674 tahmina.haider@molnlycke.com

Locations
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Belgium
Diensthoofd wondkliniek, UZ Gent Not yet recruiting
Gent, Belgium, 9000
Contact: Hilde Beele, Prof         
Principal Investigator: Hilde Beele, Prof         
AZ Delta Not yet recruiting
Roeselare, Belgium, 8800
Contact: Michel Danneels, Dr         
France
CHU Montpellier Recruiting
Montpellier, France, 34090
Contact: Nou Howaldt, Dr         
Hôpital Paris St Joseph Not yet recruiting
Paris, France, 75014
Contact: Yann Goueffic, Prof         
Germany
Franziskus-Krankenhaus Berlin Recruiting
Berlin, Germany, 10787
Contact: Berthold Amann, Dr         
Italy
"E. Profili" Civil Hospital Not yet recruiting
Fabriano, Italy, 60044
Contact: Maurizio Carnali, Dr         
Ospedale San Raffaele S.r.l. Not yet recruiting
Milano, Italy, 20132
Contact: Luca Bertoglio, Dr         
A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista Not yet recruiting
Torino, Italy, 10126
Contact: Fabio Verzini         
Università dell'Insubria, Varese Not yet recruiting
Varese, Italy, 21100
Contact: Gabriele Piffaretti, Prof         
Sponsors and Collaborators
Molnlycke Health Care AB
Syntactx
Investigators
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Principal Investigator: Hilde Beele, Prof. Dr. University Hospital, Ghent
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Responsible Party: Molnlycke Health Care AB
ClinicalTrials.gov Identifier: NCT04754048    
Other Study ID Numbers: PD-598655
First Posted: February 15, 2021    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Molnlycke Health Care AB:
Negative Pressure Wound Therapy
Post Market Clinical Follow-up
Additional relevant MeSH terms:
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Wounds and Injuries