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Completed

NCT Number: NCT04754048

Confirm the Safety and Performance of Avance Solo NPWT System

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.

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Key information

Conditions

Acute Wound Dehiscence Skin Flap Skin Graft Subacute Wound Traumatic Wound

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, 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

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 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

  • 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
  • Subjects with known allergies/hypersensitivity to product components.
  • Known pregnancy or planning to become pregnant or lactation at the time of study participation.
  • Subjects not suitable for the investigation according to the investigator's judgement and Clinical Investigation Plan and IFU.
  • 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.

Treatment and study plan

Avance Solo NPWT System

Device

Wound treatment with Avance Solo 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. 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

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 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

Acronym: ASOLO-SW

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Feb 15, 2021
Registry last updated
Feb 24, 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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