Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems (ASOLO-CW)

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Foot Ulcer; Venous Leg Ulcer; Pressure Ulcer; Chronic Ulcer
• Intervention / Treatment: Device: Avance Solo NPWT System; Device: Avance Solo Adapt NPWT System

Detailed Description

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

• Study Type: Interventional
• Enrollment (Actual): 136
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Gent, Belgium, 9000
    • Diensthoofd wondkliniek, UZ Gent
  • Roeselare, Belgium, 8800
    • AZ Delta
• Denmark
  • Hillerød, Denmark, 3400
    • North Zeeland Hospital
• France
  • Montpellier, France, 34295
    • CHU Montpellier
• Germany
  • Berlin, Germany, 10787
    • Franziskus-Krankenhaus Berlin
  • Berlin, Germany, 12200
    • Klinik fur Dermatologie, Venerologie und Allergologie Campus Benjamin Franklin
  • Bochum, Germany, 44791
    • Klinikum der Ruhr-Universität Bochum
• Ireland
  • Dublin, Ireland, D08 NHY1
    • St James's Hospital
• Italy
  • Milano, Italy, 20132
    • Ospedale San Raffaele S.r.I.
  • Torino, Italy, 10126
    • A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista
• Portugal
  • Aveiro, Portugal
    • Santa casa da Misericórdia de Aveiro
  • Guimarães, Portugal
    • Unidade de Cuidados Continuados António Francisco Guimarães
  • Touguinho, Portugal
    • Trofa Saúde Hospital Central Hospital da Trofa

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

1. Male or female ≥ 18 years.
2. Signed written informed consent.
3. 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.
4. Subjects that will be capable and willing to comply with 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 lactation at time of study participation.
9. 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

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

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Avance Solo NPWT System; Treatment with negative pressure wound therapy for Venous leg ulcers, Diabetic foot ulcers, and Pressure ulcers.	Device: Avance Solo NPWT System; Wound treatment with Avance Solo NPWT System for up to 28 days.
Experimental: Avance Solo Adapt NPWT System; Treatment with negative pressure wound therapy for Pressure ulcers.	Device: Avance Solo Adapt NPWT System; Wound treatment with Avance Solo Adapt 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
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)
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)
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
Absolute change in wound area	Absolute change in wound area 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)
Absolute change in wound volume	Absolute change in wound 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)
Percentage change in wound area	Percentage change in wound area 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)
Percentage change in wound volume	Percentage change in wound 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)
Exudate amount	Change in exudate amount using a category scoring system from baseline to all follow-up visits. Amount: none, low, moderate, or high)	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate nature	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	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Exudate odor	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	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 or Avance Solo Adapt Film 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)
Trauma	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.	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Quality of life assessed using Numeric Rating Scale (NRS)	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	28 days
Alarms	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	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 the provided 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)
Ability to absorb and/or transport exudate via clinical judgement	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	Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Ease of application	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.	Baseline, 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 systems in regards to: Very dissatisfied; Dissatisfied; Neither satisfied or dissatisfied; Satisfied; Very satisfied	28 days
Product consumption	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	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 or Avance®Solo Adapt 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)

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 14, 2021
• Primary Completion (Actual): July 15, 2023
• Study Completion (Actual): July 21, 2023

Study Registration Dates

• First Submitted: February 9, 2021
• First Submitted That Met QC Criteria: February 10, 2021
• First Posted (Actual): February 15, 2021

Study Record Updates

• Last Update Posted (Actual): September 8, 2023
• Last Update Submitted That Met QC Criteria: September 7, 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: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Endocrine System Diseases; Diabetic Angiopathies; Skin Ulcer; Diabetes Complications; Diabetes Mellitus; Diabetic Neuropathies; Foot Diseases; Varicose Veins; Diabetic Foot; Foot Ulcer; Ulcer; Leg Ulcer; Varicose Ulcer; Pressure Ulcer; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Antiemetics; Gastrointestinal Agents; Tranquilizing Agents; Psychotropic Drugs; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; GABA Modulators; GABA Agents; Anticonvulsants; Neuromuscular Agents; Muscle Relaxants, Central; Diazepam
• Other Study ID Numbers: PD-598654

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