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

Diabetic Foot Ulcer Clinical Trial

— ASOLO-CW  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04753294
• Other study ID #: PD-598654
• Status: Completed
• Phase: N/A
• Start date: June 14, 2021
• Est. completion date: July 21, 2023

Study information

• Verified date: February 2023
• Source: Molnlycke Health Care AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: July 21, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Ulcer
• Diabetic Foot
• Diabetic Foot Ulcer
• Foot Ulcer
• Leg Ulcer
• Pressure Ulcer
• Ulcer
• Varicose Ulcer
• Venous Leg Ulcer

Intervention

Device:
• Avance Solo NPWT System
Wound treatment with Avance Solo NPWT System for up to 28 days.
• Avance Solo Adapt NPWT System
Wound treatment with Avance Solo Adapt NPWT System for up to 28 days.

Locations

Country	Name	City	State
Belgium	Diensthoofd wondkliniek, UZ Gent	Gent
Belgium	AZ Delta	Roeselare
Denmark	North Zeeland Hospital	Hillerød
France	CHU Montpellier	Montpellier
Germany	Franziskus-Krankenhaus Berlin	Berlin
Germany	Klinik fur Dermatologie, Venerologie und Allergologie Campus Benjamin Franklin	Berlin
Germany	Klinikum der Ruhr-Universität Bochum	Bochum
Ireland	St James's Hospital	Dublin
Italy	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
Portugal	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

Sponsors (2)

Lead Sponsor	Collaborator
Molnlycke Health Care AB	Syntactx

Countries where clinical trial is conducted

Belgium,  Denmark,  France,  Germany,  Ireland,  Italy,  Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Wound progress	Wound progress compared between baseline and final visit and assessed as: Deteriorated; No change; Improved	28 days
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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
Secondary	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)
Secondary	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)