Confirm the Safety and Performance of Avance Solo NPWT System
- Conditions
- Skin GraftDehiscenceAcute WoundSubacute WoundTraumatic WoundSkin Flap
- Interventions
- Device: Avance Solo NPWT System
- Registration Number
- NCT04754048
- Lead Sponsor
- Molnlycke Health Care AB
- 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.
- 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:
* Deteriorated
* No change
* Improved
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 105
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Subacute wounds (e.g., dehisced wounds) Avance Solo NPWT System Treatment with negative pressure wound therapy. Traumatic wounds Avance Solo NPWT System Treatment with negative pressure wound therapy. Flaps and Grafts Avance Solo NPWT System Treatment with negative pressure wound therapy.
- Primary Outcome Measures
Name Time Method 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
Name Time Method Wound progress 28 days Wound progress compared between baseline and final visit and assessed as:
* Deteriorated
* No change
* ImprovedTissue 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.
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
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 strongPeri-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
* InduratedAbsorb 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
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
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 satisfiedWound 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.
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.
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
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.
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.
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
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 20Product 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
Trial Locations
- Locations (10)
CHU Montpellier
🇫🇷Montpellier, France
Hôpital Paris St Joseph
🇫🇷Paris, France
Franziskus-Krankenhaus Berlin
🇩🇪Berlin, Germany
"E. Profili" Civil Hospital
🇮🇹Fabriano, Italy
Ospedale San Raffaele S.r.l.
🇮🇹Milano, Italy
UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Lübeck
🇩🇪Lübeck, Germany
A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista
🇮🇹Torino, Italy
Università dell'Insubria, Varese
🇮🇹Varese, Italy
Diensthoofd wondkliniek, UZ Gent
🇧🇪Gent, Belgium
AZ Delta
🇧🇪Roeselare, Belgium