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

Molnlycke Health Care AB136 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

136

Conditions

Venous Leg Ulcer Pressure Ulcer Diabetic Foot Ulcer Chronic Ulcer

Interventions

Avance Solo NPWT SystemDEVICE

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

Avance Solo Adapt NPWT SystemDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (13)

Diensthoofd wondkliniek, UZ Gent

Ghent, Belgium

AZ Delta

Roeselare, Belgium

North Zeeland Hospital

Hillerød, Denmark

Outcomes

Primary Outcomes

Change in wound progress

Wound progress compared to last visit and assessed as: * Deteriorated * No change * Improved

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

Secondary Outcomes

Wound progress

Wound progress compared between baseline and final visit and assessed as: * Deteriorated * No change * Improved

Time frame: 28 days

Absolute change in wound area

Absolute change in wound area from baseline to all follow-up visits

Time frame: 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

Absolute change in wound volume from baseline to all follow-up visits

Time frame: 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

Percentage change in wound area from baseline to all follow-up visits

Time frame: 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

Percentage change in wound volume from baseline to all follow-up visits

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

Tissue type

Change in tissue type (slough, necrotic, granulation or epithelization) from baseline to all follow-up visits.

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

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

CHU Montpellier

Montpellier, France

Franziskus-Krankenhaus Berlin

Berlin, Germany

Klinik fur Dermatologie, Venerologie und Allergologie Campus Benjamin Franklin

Berlin, Germany

Klinikum der Ruhr-Universität Bochum

Bochum, Germany

St James's Hospital

Dublin, Ireland

Ospedale San Raffaele S.r.I.

Milan, Italy

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

Torino, Italy

...and 3 more locations

Exudate amount

Change in exudate amount using a category scoring system from baseline to all follow-up visits. Amount: none, low, moderate, or high)

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

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

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

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

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

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

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

Tissue in-growth

Degree of tissue in-growth when Avance Solo foam is utilized at all follow-up visits as well as extra visits.

Time frame: 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

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.

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

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.

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

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

Time frame: 28 days

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

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

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.

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

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

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

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.

Time frame: Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

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

Time frame: 28 days

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

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

Wear time

Evaluate Avance®Solo or Avance®Solo Adapt wear time in days from baseline to all follow-up visits including potential extra visits

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