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

NCT04753294 | Completed

• 1 other identifier: PD-598654
• Study Type: interventional
• Target: 136
• Locations: 7 countries
• Sites: 13

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.

Conditions

Venous Leg Ulcer; Pressure Ulcer; Diabetic Foot Ulcer; Chronic Ulcer

Keywords

Negative Pressure Wound Therapy; Post Market Clinical Follow-up

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (21)

• Wound progress

  28 days

• 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 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 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 volume

  Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

Study Arms (2)

Avance Solo NPWT System

EXPERIMENTAL

Treatment with negative pressure wound therapy for Venous leg ulcers, Diabetic foot ulcers, and Pressure ulcers.

Device: Avance Solo NPWT System

Avance Solo Adapt NPWT System

EXPERIMENTAL

Treatment with negative pressure wound therapy for Pressure ulcers.

Device: Avance Solo Adapt NPWT System

Interventions

Avance Solo NPWT System DEVICE

Wound treatment with Avance Solo NPWT System for up to 28 days.

Avance Solo NPWT System

Avance Solo Adapt NPWT System DEVICE

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

Avance Solo Adapt NPWT System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Molnlycke Health Care AB: lead
• Syntactx: collaborator

Study Sites (13)

Diensthoofd wondkliniek, UZ Gent

Ghent, 9000, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

North Zeeland Hospital

Hillerød, 3400, Denmark

Location

CHU Montpellier

Montpellier, 34295, France

Location

Franziskus-Krankenhaus Berlin

Berlin, 10787, Germany

Location

Klinik fur Dermatologie, Venerologie und Allergologie Campus Benjamin Franklin

Berlin, 12200, Germany

Location

Klinikum der Ruhr-Universität Bochum

Bochum, 44791, Germany

Location

St James's Hospital

Dublin, D08 NHY1, Ireland

Location

Ospedale San Raffaele S.r.I.

Milan, 20132, Italy

Location

A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista

Torino, 10126, Italy

Location

Santa casa da Misericórdia de Aveiro

Aveiro, Portugal

Location

Unidade de Cuidados Continuados António Francisco Guimarães

Guimarães, Portugal

Location

Trofa Saúde Hospital Central Hospital da Trofa

Touguinho, Portugal

Location

MeSH Terms

Conditions

Varicose Ulcer; Pressure Ulcer; Diabetic Foot

Condition Hierarchy (Ancestors)

Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Diabetic Angiopathies; Foot Ulcer; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Diabetic Neuropathies

Study Officials

• Hilde Beele, Prof. Dr.

  University Hospital, Ghent

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: February 9, 2021
• First Posted: February 15, 2021
• Study Start: June 14, 2021
• Primary Completion: July 15, 2023
• Study Completion: July 21, 2023
• Last Updated: September 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1); DE (3); PT (3); DK (1); BE (2); IT (2); IE (1)