Confirm the Safety and Performance of Avance Solo NPWT System

Molnlycke Health Care AB105 enrolled

Overview

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

Conditions

Acute Wound Traumatic Wound Skin Graft Skin Flap Subacute Wound Dehiscence

Interventions

Avance Solo NPWT SystemDEVICE

Wound treatment with Avance Solo NPWT System for up to 28 days.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Male or female ≥ 18 years. 2. Signed written informed consent. 3. 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: 1. Known malignancy in the wound or margins of the wound 2. Untreated and previously confirmed osteomyelitis 3. Non-enteric and unexplored fistulas 4. Necrotic tissue with eschar present 5. Exposed nerves, arteries, veins or organs 6. Exposed anastomotic site 7. Subjects with known allergies/hypersensitivity to product components. 8. Known pregnancy or planning to become pregnant or lactation at the time of study participation. 9. Subjects not suitable for the investigation according to the investigator's judgement and Clinical Investigation Plan and IFU. 10. 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.

Locations (10)

Diensthoofd wondkliniek, UZ Gent

Ghent, Belgium

AZ Delta

Roeselare, Belgium

CHU Montpellier

Montpellier, France

Hôpital Paris St Joseph

Paris, France

Outcomes

Primary Outcomes

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)

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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