Clinical trial NCT04753294: Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Venous Leg Ulcer
Pressure Ulcer
Diabetic Foot Ulcer
Chronic Ulcer
Keywords: Negative Pressure Wound Therapy
Post Market Clinical Follow-up
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
Collaborators: name: Syntactx
First posted: 2021-02-15
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Four different patient groups treated with the Avance Solo NPWT System or Avance Solo Adapt NPWT System.
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Change in wound progress
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary outcomes:
measure: Wound progress
timeFrame: 28 days
measure: Absolute change in wound area
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Absolute change in wound volume
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Percentage change in wound area
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Percentage change in wound volume
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Tissue type
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Exudate amount
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Exudate nature
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Exudate odor
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Peri-wound
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Tissue in-growth
timeFrame: 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
measure: Pain assessment
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Trauma
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Quality of life assessed using Numeric Rating Scale (NRS)
timeFrame: 28 days
measure: Alarms
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Compliance
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Ability to absorb and/or transport exudate via clinical judgement
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Ease of application
timeFrame: Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Global satisfaction
timeFrame: 28 days
measure: Product consumption
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Wear time
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Diensthoofd wondkliniek, UZ Gent
city: Roeselare
country: Belgium
facility: AZ Delta
city: Hillerød
country: Denmark
facility: North Zeeland Hospital
city: Montpellier
country: France
facility: CHU Montpellier
city: Berlin
country: Germany
facility: Franziskus-Krankenhaus Berlin
city: Berlin
country: Germany
facility: Klinik fur Dermatologie, Venerologie und Allergologie Campus Benjamin Franklin
city: Bochum
country: Germany
facility: Klinikum der Ruhr-Universität Bochum
city: Dublin
country: Ireland
facility: St James's Hospital
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.I.
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista
city: Aveiro
country: Portugal
facility: Santa casa da Misericórdia de Aveiro
city: Guimarães
country: Portugal
facility: Unidade de Cuidados Continuados António Francisco Guimarães
city: Touguinho
country: Portugal
facility: Trofa Saúde Hospital Central Hospital da Trofa
Study officials:
affiliation: University Hospital, Ghent
name: Hilde Beele, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: