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

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

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.

Study Overview

• Status: Completed
• Conditions: Acute Wound; Skin Graft; Skin Flap; Traumatic Wound; Dehiscence; Subacute Wound
• Intervention / Treatment: Device: Avance Solo NPWT System

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

• Study Type: Interventional
• Enrollment (Actual): 105
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Diensthoofd wondkliniek, UZ Gent
  • Roeselare, Belgium, 8800
    • AZ Delta
• France
  • Montpellier, France, 34090
    • CHU Montpellier
  • Paris, France, 75014
    • Hôpital Paris St Joseph
• Germany
  • Berlin, Germany, 10787
    • Franziskus-Krankenhaus Berlin
  • Lübeck, Germany, D- 23538
    • Universitätsklinikum Schleswig-Holstein Campus Lübeck
• Italy
  • Fabriano, Italy, 60044
    • "E. Profili" Civil Hospital
  • Milano, Italy, 20132
    • Ospedale San Raffaele S.r.l.
  • Torino, Italy, 10126
    • A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista
  • Varese, Italy, 21100
    • Università dell'Insubria, Varese

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in wound progress	Wound progress compared to last visit and assessed as: Deteriorated; No change; Improved	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound progress	Wound progress compared between baseline and final visit and assessed as: Deteriorated; No change; Improved	28 days
Wound dimension	Absolute and percentage change in wound area and volume from baseline to all follow-up visits.	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Tissue type	Change in tissue type (slough, necrotic, granulation or epithelization) from baseline to all follow-up visits.	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate	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	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Peri-wound	Change in peri-wound skin condition from baseline to all follow-up visits using the following conditions: Normal; Erythematous; Oedematous; Eczematous; Excoriated; Macerated; Indurated	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Pain assessment	Subject evaluation of pain at Avance Solo dressing removal using Numeric Rating Scale (NRS) at each follow-up visit.	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Absorb and transport of exudate	Clinician evaluation of Avance Solo NPWT System ability to absorb and transport exudate assessed at all follow-up visits	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Tissue in-growth	Degree of tissue in-growth when Avance Solo foam is utilized at all follow-up visits as well as extra visits.	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
Trauma	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	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Graft take	Change in percentage of graft take and wound epithelization from baseline to all follow-up visits	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Flap survival	Change in percentage of flap survival from baseline to all follow-up visits	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Wear time	Evaluate Avance Solo NPWT System wear time in days from baseline to all follow-up visits including potential extra visits	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Alarms	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	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Product consumption	Product consumption of the utilized products for the Avance Solo NPWT System, from baseline and final visit using the Avance Solo NPWT System	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Quality of life assessment	Subject evaluation of the Avance Solo NPWT system impact of everyday life	28 days
Ease of application	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.	Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Compliance	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.	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Global satisfaction	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	28 days

Collaborators and Investigators

• Sponsor: Molnlycke Health Care AB
• Collaborators: Syntactx
• Investigators: Principal Investigator: Hilde Beele, Prof. Dr., University Hospital, Ghent

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2021
• Primary Completion (Actual): December 6, 2022
• Study Completion (Actual): December 6, 2022

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 12, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): February 24, 2023
• Last Update Submitted That Met QC Criteria: February 23, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Negative Pressure Wound Therapy; Post Market Clinical Follow-up
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: PD-598655

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No