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.
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
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
105
Wound treatment with Avance Solo NPWT System for up to 28 days.
Diensthoofd wondkliniek, UZ Gent
Ghent, Belgium
AZ Delta
Roeselare, Belgium
CHU Montpellier
Montpellier, France
Hôpital Paris St Joseph
Paris, France
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)
Wound progress
Wound progress compared between baseline and final visit and assessed as: * Deteriorated * No change * Improved
Time frame: 28 days
Wound dimension
Absolute and percentage change in wound area and 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)
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
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)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Franziskus-Krankenhaus Berlin
Berlin, Germany
UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Lübeck
Lübeck, Germany
"E. Profili" Civil Hospital
Fabriano, Italy
Ospedale San Raffaele S.r.l.
Milan, Italy
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
Pain assessment
Subject evaluation of pain at Avance Solo dressing 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)
Absorb and transport of exudate
Clinician evaluation of Avance Solo NPWT System ability to absorb and transport exudate assessed 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)
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
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
Time frame: 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
Time frame: 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
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 NPWT System 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)
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
Time frame: 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
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 assessment
Subject evaluation of the Avance Solo NPWT system impact of everyday life
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 28 days