Clinical trial NCT04754048: Confirm the Safety and Performance of Avance Solo NPWT System
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Wound
Traumatic Wound
Skin Graft
Skin Flap
Subacute Wound
Dehiscence
Keywords: Negative Pressure Wound Therapy
Post Market Clinical Follow-up
Lead sponsor: Molnlycke Health Care AB
Sponsor class: INDUSTRY
Collaborators: name: Syntactx
First posted: 2021-02-15
Enrollment: 105
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Intervention model description: Three different patient groups treated with the Avance Solo NPWT System
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Change in wound progress
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
Secondary outcomes:
measure: Wound progress
timeFrame: 28 days
measure: Wound dimension
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Tissue type
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Exudate
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Peri-wound
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Pain assessment
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Absorb and transport of exudate
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Tissue in-growth
timeFrame: 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
measure: Trauma
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Graft take
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Flap survival
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Wear time
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Alarms
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Product consumption
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Quality of life assessment
timeFrame: 28 days
measure: Ease of application
timeFrame: Baseline, Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Compliance
timeFrame: Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)
measure: Global satisfaction
timeFrame: 28 days
Other outcomes:
Locations:
city: Gent
country: Belgium
facility: Diensthoofd wondkliniek, UZ Gent
city: Roeselare
country: Belgium
facility: AZ Delta
city: Montpellier
country: France
facility: CHU Montpellier
city: Paris
country: France
facility: Hôpital Paris St Joseph
city: Berlin
country: Germany
facility: Franziskus-Krankenhaus Berlin
city: Lübeck
country: Germany
facility: UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Lübeck
city: Fabriano
country: Italy
facility: "E. Profili" Civil Hospital
city: Milano
country: Italy
facility: Ospedale San Raffaele S.r.l.
city: Torino
country: Italy
facility: A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista
city: Varese
country: Italy
facility: Università dell'Insubria, Varese
Study officials:
affiliation: University Hospital, Ghent
name: Hilde Beele, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: