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

Study Overview
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Brief Summary
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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
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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

Official Title
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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

Conditions
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Pressure Ulcer, Venous Leg Ulcer, Diabetic Foot Ulcer, Chronic Ulcer

Intervention / Treatment
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* Device: Avance Solo NPWT System
* Device: Avance Solo Adapt NPWT System


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Four different patient groups treated with the Avance Solo NPWT System or Avance Solo Adapt NPWT System.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Avance Solo NPWT System<br>Treatment with negative pressure wound therapy for Venous leg ulcers, Diabetic foot ulcers, and Pressure ulcers. | Device: Avance Solo NPWT System<br>* Wound treatment with Avance Solo NPWT System for up to 28 days.<br>|
| Experimental: Avance Solo Adapt NPWT System<br>Treatment with negative pressure wound therapy for Pressure ulcers. | Device: Avance Solo Adapt NPWT System<br>* Wound treatment with Avance Solo Adapt NPWT System for up to 28 days.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound progress | Wound progress compared between baseline and final visit and assessed as: Deteriorated No change Improved | 28 days | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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) | 
| 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) | 
| 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 | 
| 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) | 
| 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) | 
| 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) | 
| 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) | 
| 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 | 
| 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) | 
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Negative Pressure Wound Therapy, Post Market Clinical Follow-up