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

Sponsor

Molnlycke Health Care AB (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04753294

Collaborator

Syntactx (Other)

136

Enrollment

Locations

Arms

9.2

Anticipated Duration (Months)

11.3

Patients Per Site

1.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Venous Leg Ulcer Pressure Ulcer Diabetic Foot Ulcer Chronic Ulcer	Device: Avance Solo NPWT System Device: Avance Solo Adapt NPWT System	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

136 participants

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Intervention Model Description:

Four different patient groups treated with the Avance Solo NPWT System or Avance Solo Adapt NPWT System.Four different patient groups treated with the Avance Solo NPWT System or Avance Solo Adapt NPWT System.

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official 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

Actual Study Start Date :

Jun 14, 2021

Anticipated Primary Completion Date :

Feb 21, 2022

Anticipated Study Completion Date :

Mar 21, 2022

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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

Wound progress [28 days]
Wound progress compared between baseline and final visit and assessed as: Deteriorated No change Improved
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
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
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
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)
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 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.
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.
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.
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
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
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.
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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Diensthoofd wondkliniek, UZ Gent	Gent	Belgium	9000
2	AZ Delta	Roeselare	Belgium	8800
3	CHU Montpellier	Montpellier	France	34295
4	Franziskus-Krankenhaus Berlin	Berlin	Germany	10787
5	Klinik fur Dermatologie, Venerologie und Allergologie Campus Benjamin Franklin	Berlin	Germany	12200
6	Klinikum der Ruhr-Universität Bochum	Bochum	Germany	44791
7	St James's Hospital	Dublin	Ireland	D08 NHY1
8	Ospedale San Raffaele S.r.I.	Milano	Italy	20132
9	A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista	Torino	Italy	10126
10	Santa casa da Misericórdia de Aveiro	Aveiro	Portugal
11	Unidade de Cuidados Continuados António Francisco Guimarães	Guimarães	Portugal
12	Trofa Saúde Hospital Central Hospital da Trofa	Touguinho	Portugal