Confirm the Safety and Performance of Avance Solo NPWT System

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 safety and performance of Avance® Solo NPWT System in low to moderate exuding acute (traumatic wounds and flaps and grafts), as well as subacute (e.g., dehisced wounds) 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, non-comparative, PMCF investigation to confirm safety and performance of Avance Solo NPWT System in subjects with traumatic wounds (n=34), subacute (e.g., dehisced wounds) wounds (n=34), and flaps and grafts (n=34). This is a multi-center study that will take place in approximately 5 European countries. The eligible subjects will be both in and out patients and all will be treated with Avance Solo NPWT System, for up to 28 days. Treatment will be stopped if the wound is considered healed, has a high enough percentage of graft take, or enough flap viability by the judgement of the clinicians before the complete treatment time (28 days). 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 be assessed 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 Safety and Performance of Avance Solo NPWT System in Low to Moderate Exuding Acute (Traumatic Wounds and Flaps and Grafts), as Well as Subacute (e.g., Dehisced Wounds) Wounds

Conditions
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Acute Wound, Traumatic Wound, Skin Graft, Skin Flap, Subacute Wound, Dehiscence

Intervention / Treatment
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* Device: Avance Solo 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 acute (traumatic wound, or a flap/graft) or subacute (e.g., dehisced wounds) wounds suitable for single use NPWT according to the investigator´s judgement and Instructions for Use 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 Subjects with known allergies/hypersensitivity to product components. Known pregnancy or planning to become pregnant or lactation at the time of study participation. Subjects not suitable for the investigation according to the investigator's judgement and Clinical Investigation Plan and IFU. Participating in other ongoing clinical investigation, or during the past 30 days that may impact the outcome of this investigation based on the judgement of the investigator.

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: Three different patient groups treated with the Avance Solo NPWT System
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traumatic wounds<br>Treatment with negative pressure wound therapy. | Device: Avance Solo NPWT System<br>* Wound treatment with Avance Solo NPWT System for up to 28 days.<br>|
| Experimental: Subacute wounds (e.g., dehisced wounds)<br>Treatment with negative pressure wound therapy. | Device: Avance Solo NPWT System<br>* Wound treatment with Avance Solo NPWT System for up to 28 days.<br>|
| Experimental: Flaps and Grafts<br>Treatment with negative pressure wound therapy. | Device: Avance Solo NPWT System<br>* Wound treatment with Avance Solo 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 | 
| Wound dimension | Absolute and percentage change in wound area and 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 | Change in exudate amount, nature, and odor using a category scoring system from baseline to all follow-up visits. Amount: none, low, moderate, or high Nature: serous, fibrinous, serosanguineous, sanguineous, seropurulent, purulent, foul purulent, heamopurulent, or hemorrhagic Odor: No odor, slight, moderate, strong, 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) | 
| Pain assessment | Subject evaluation of pain at Avance Solo dressing 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) | 
| Absorb and transport of exudate | Clinician evaluation of Avance Solo NPWT System ability to absorb and transport exudate assessed 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) | 
| 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 | 
| Trauma | Proportion of subjects with trauma to the wound site and surrounding skin for Avance Solo Border Dressing and also Avance Solo fixation strips 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) | 
| Graft take | Change in percentage of graft take and wound 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) | 
| Flap survival | Change in percentage of flap survival 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) | 
| Wear time | Evaluate Avance Solo NPWT System 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) | 
| Alarms | Subject evaluation of the Avance Solo NPWT 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) | 
| Product consumption | Product consumption of the utilized products for the Avance Solo NPWT System, from baseline and final visit using the Avance Solo NPWT System | Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days) | 
| Quality of life assessment | Subject evaluation of the Avance Solo NPWT system impact of everyday life | 28 days | 
| Ease of application | Clinician evaluation of ease of application and removal of the Avance Solo NPWT System 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) | 
| Compliance | Evaluate the compliance to Avance Solo NPWT System 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) | 
| Global satisfaction | Evaluate the investigator and subject global satisfaction of the Avance Solo NPWT System in regards to: Very dissatisfied Dissatisfied Neither satisfied or dissatisfied Satisfied Very satisfied | 28 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