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Completed

NCT Number: NCT04753294

Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems

The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.

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Key information

Conditions

Venous Leg Ulcer Cardiovascular Diseases Chronic Ulcer Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Diabetic Foot Diabetic Foot Ulcer Diabetic Neuropathies Endocrine System Diseases Foot Ulcer Leg Ulcer Pressure Ulcer Skin Diseases Skin Ulcer Skin and Connective Tissue Diseases Varicose Ulcer Varicose Veins Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Diensthoofd wondkliniek, UZ Gent, Ghent, Belgium

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About this study

This investigation is designed as a prospective, open and non-comparative PMCF investigation to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt in low to moderate exuding chronic wounds. This is a multi-center study that will take place in approximately 5 European countries. The target subjects are male or female, 18 years or older with low to moderate exuding chronic wounds (pressure ulcers (N=68), diabetic foot ulcers (N=34), and venous leg ulcers (N=34)) suitable for NPWT as deemed by the investigator. Two different options of Negative Pressure Wound Therapies (NPWT) will be evaluated through this clinical investigation

A total of 136 subjects will receive treatment with the investigational devices within the intended use according to Instructions for Use (IfU): Group 1: 102 subjects in total, 34 subjects per indication (pressure ulcers, diabetic foot ulcers, and venous leg ulcers) treated with Avance®Solo and Group 2: 34 subjects with pressure ulcers treated with Avance®Solo Adapt. Subjects will be managed and monitored for a maximum of 4 weeks or until withdrawal from investigation for any reason.

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 take into account all aspects of wound characteristics. Wound progression will be assessed by the Investigator at each follow-up visit and measured by three outcomes:

  • Deteriorated
  • No change
  • Improved

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female ≥ 18 years.
  • Signed written informed consent.
  • Low to moderate exuding chronic wounds (diabetic foot ulcers, venous leg ulcers and pressure ulcers for Avance®Solo or pressure ulcers for Avance®Solo Adapt) suitable for NPWT according to the investigator´s judgement and Instructions for Use.
  • Subjects that will be capable and willing to comply with 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 lactation 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

Treatment and study plan

Avance Solo NPWT System

Device

Wound treatment with Avance Solo NPWT System for up to 28 days.

Avance Solo Adapt NPWT System

Device

Wound treatment with Avance Solo Adapt NPWT System for up to 28 days.

Primary outcomes

  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 outcomes

  1. Wound progress

    Time frame: 28 days

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

    • Deteriorated
    • No change
    • Improved

  2. Absolute change in wound area

    Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

    Absolute change in wound area from baseline to all follow-up visits

  3. Absolute change in wound volume

    Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

    Absolute change in wound volume from baseline to all follow-up visits

  4. Percentage change in wound area

    Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

    Percentage change in wound area from baseline to all follow-up visits

  5. Percentage change in wound volume

    Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

    Percentage change in wound volume from baseline to all follow-up visits

  6. 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.

  7. Exudate amount

    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 using a category scoring system from baseline to all follow-up visits.

    Amount: none, low, moderate, or high)

  8. Exudate nature

    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 nature using a category scoring system from baseline to all follow-up visits.

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

  9. Exudate odor

    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 odor using a category scoring system from baseline to all follow-up visits.

    Odor: no odor, slight, moderate, strong, and very strong

  10. 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

  11. 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.

  12. 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 or Avance Solo Adapt Film removal using Numeric Rating Scale (NRS) at each follow-up visit.

  13. 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, fixation strips or Avance Solo Adapt Film at all follow-up visits.

  14. Quality of life assessed using Numeric Rating Scale (NRS)

    Time frame: 28 days

    Impact of everyday life by the systems will be captured through a NRS scale where the subject grade how much the treatment has affected the subject's daily life. 0 is equal to no influence and 10 to considerable influence on everyday life or unbearable.

    If replying >0, the subject will state the presence or absence of the following causes:

    • Leakage of dressing
    • Impaired mobility
    • Difficulties in getting dressed
    • Pain
    • Odor

  15. 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 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

  16. 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 the provided therapy by average number of hours per 24h that the system has not provided treatment since last visit.

  17. Ability to absorb and/or transport exudate via clinical judgement

    Time frame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

    Evaluation of the Systems ability to absorb and/or transport exudate assessed using a rating scale by the clinician/designee:

    • Very Poor
    • Poor
    • Good
    • Very Good

  18. 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 Avance®Solo or Avance®Solo Adapt using a Numeric Rating Scale (NRS) collected at baseline, and each follow-up visit.

  19. Global satisfaction

    Time frame: 28 days

    Evaluate the investigator and subject global satisfaction of the systems in regards to:

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

  20. 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 system's, from baseline and final visit using the Avance Solo or Avance Solo Adapt NPWT System

  21. 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 or Avance®Solo Adapt wear time in days from baseline to all follow-up visits including potential extra visits

Sponsors and collaborators

Lead sponsor

Molnlycke Health Care AB

Industry

Collaborators

  • Syntactx

Registry information

Official study title

A Prospective, Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm the Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems in Low to Moderate Exuding Chronic Wounds

Acronym: ASOLO-CW

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Feb 15, 2021
Registry last updated
Sep 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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