ASOLO-SW: Confirm the Safety and Performance of Avance Solo NPWT System
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Detailed Description
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:
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Deteriorated
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No change
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Improved
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Traumatic wounds Treatment with negative pressure wound therapy. |
Device: Avance Solo NPWT System
Wound treatment with Avance Solo NPWT System for up to 28 days.
|
| Experimental: Subacute wounds (e.g., dehisced wounds) Treatment with negative pressure wound therapy. |
Device: Avance Solo NPWT System
Wound treatment with Avance Solo NPWT System for up to 28 days.
|
| Experimental: Flaps and Grafts Treatment with negative pressure wound therapy. |
Device: Avance Solo NPWT System
Wound treatment with Avance Solo NPWT System for up to 28 days.
|
Outcome Measures
Primary Outcome Measures
- Change in wound progress [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
Wound progress compared to last visit and assessed as: Deteriorated No change Improved
Secondary Outcome Measures
- Wound progress [28 days]
Wound progress compared between baseline and final visit and assessed as: Deteriorated No change Improved
- Wound dimension [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
Absolute and percentage change in wound area and volume from baseline to all follow-up visits.
- Tissue type [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
Change in tissue type (slough, necrotic, granulation or epithelization) from baseline to all follow-up visits.
- Exudate [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
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
- Peri-wound [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
Change in peri-wound skin condition from baseline to all follow-up visits using the following conditions: Normal Erythematous Oedematous Eczematous Excoriated Macerated Indurated
- Pain assessment [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
Subject evaluation of pain at Avance Solo dressing removal using Numeric Rating Scale (NRS) at each follow-up visit.
- Absorb and transport of exudate [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
Clinician evaluation of Avance Solo NPWT System ability to absorb and transport exudate assessed at all follow-up visits
- Tissue in-growth [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]
Degree of tissue in-growth when Avance Solo foam is utilized at all follow-up visits as well as extra visits.
- Trauma [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
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
- Graft take [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
Change in percentage of graft take and wound epithelization from baseline to all follow-up visits
- Flap survival [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
Change in percentage of flap survival from baseline to all follow-up visits
- Wear time [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
Evaluate Avance Solo NPWT System wear time in days from baseline to all follow-up visits including potential extra visits
- Alarms [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
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
- Product consumption [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
Product consumption of the utilized products for the Avance Solo NPWT System, from baseline and final visit using the Avance Solo NPWT System
- Quality of life assessment [28 days]
Subject evaluation of the Avance Solo NPWT system impact of everyday life
- Ease of application [Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
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.
- Compliance [Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)]
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.
- Global satisfaction [28 days]
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
Eligibility Criteria
Criteria
Inclusion Criteria:
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Male or female ≥ 18 years.
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Signed written informed consent.
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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:
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Known malignancy in the wound or margins of the wound
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Untreated and previously confirmed osteomyelitis
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Non-enteric and unexplored fistulas
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Necrotic tissue with eschar present
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Exposed nerves, arteries, veins or organs
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Exposed anastomotic site
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Subjects with known allergies/hypersensitivity to product components.
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Known pregnancy or planning to become pregnant or lactation at the time of study participation.
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Subjects not suitable for the investigation according to the investigator's judgement and Clinical Investigation Plan and IFU.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Diensthoofd wondkliniek, UZ Gent | Gent | Belgium | 9000 | |
| 2 | AZ Delta | Roeselare | Belgium | 8800 | |
| 3 | CHU Montpellier | Montpellier | France | 34090 | |
| 4 | Hôpital Paris St Joseph | Paris | France | 75014 | |
| 5 | Franziskus-Krankenhaus Berlin | Berlin | Germany | 10787 | |
| 6 | "E. Profili" Civil Hospital | Fabriano | Italy | 60044 | |
| 7 | Ospedale San Raffaele S.r.l. | Milano | Italy | 20132 | |
| 8 | A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista | Torino | Italy | 10126 | |
| 9 | Università dell'Insubria, Varese | Varese | Italy | 21100 |
Sponsors and Collaborators
- Molnlycke Health Care AB
- Syntactx
Investigators
- Principal Investigator: Hilde Beele, Prof. Dr., University Hospital, Ghent
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PD-598655