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

Not Applicable

Completed

• Conditions: Chronic Ulcer; Pressure Ulcer; Diabetic Foot Ulcer; Venous Leg Ulcer
• Interventions: Device: Avance Solo Adapt NPWT System; Device: Avance Solo NPWT System

• Registration Number: NCT04753294
• Lead Sponsor: Molnlycke Health Care AB

Brief Summary

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.

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 Timeline

• Study First Submitted: 2021-02-09
• Study First Submitted QC: 2021-02-10
• Study First Posted: 2021-02-15
• Study Start: 2021-06-14
• Status Verified: 2023-02
• Primary Completion: 2023-07-15
• Study Completion: 2023-07-21
• Last Update Submitted: 2023-09-07
• Last Update Posted: 2023-09-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Avance Solo Adapt NPWT System	Avance Solo Adapt NPWT System	Treatment with negative pressure wound therapy for Pressure ulcers.
Avance Solo NPWT System	Avance Solo NPWT System	Treatment with negative pressure wound therapy for Venous leg ulcers, Diabetic foot ulcers, and Pressure ulcers.

Primary Outcome Measures

Name	Time	Method
Change in wound progress	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

Name	Time	Method
Percentage change in wound area	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
Trauma	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.
Wound progress	28 days	Wound progress compared between baseline and final visit and assessed as: * Deteriorated; * No change; * Improved
Quality of life assessed using Numeric Rating Scale (NRS)	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
Ease of application	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.
Global satisfaction	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
Percentage change in wound volume	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
Pain assessment	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.
Alarms	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
Absolute change in wound area	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
Absolute change in wound volume	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
Exudate nature	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
Exudate odor	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
Peri-wound	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
Tissue type	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.
Exudate amount	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)
Tissue in-growth	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.
Compliance	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.
Wear time	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
Ability to absorb and/or transport exudate via clinical judgement	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
Product consumption	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

Trial Locations

Locations (13)

AZ Delta; 🇧🇪 Roeselare, Belgium

North Zeeland Hospital; 🇩🇰 Hillerød, Denmark

Diensthoofd wondkliniek, UZ Gent; 🇧🇪 Gent, Belgium

Franziskus-Krankenhaus Berlin; 🇩🇪 Berlin, Germany

Klinik fur Dermatologie, Venerologie und Allergologie Campus Benjamin Franklin; 🇩🇪 Berlin, Germany

CHU Montpellier; 🇫🇷 Montpellier, France

Klinikum der Ruhr-Universität Bochum; 🇩🇪 Bochum, Germany

St James's Hospital; 🇮🇪 Dublin, Ireland

Ospedale San Raffaele S.r.I.; 🇮🇹 Milano, Italy

A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista; 🇮🇹 Torino, Italy

Santa casa da Misericórdia de Aveiro; 🇵🇹 Aveiro, Portugal

Unidade de Cuidados Continuados António Francisco Guimarães; 🇵🇹 Guimarães, Portugal

Trofa Saúde Hospital Central Hospital da Trofa; 🇵🇹 Touguinho, Portugal