NCT04754048

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
105

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2021

Geographic Reach
4 countries

10 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2021

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 15, 2021

Completed
4 months until next milestone

Study Start

First participant enrolled

June 15, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 6, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 6, 2022

Completed
Last Updated

February 24, 2023

Status Verified

February 1, 2023

Enrollment Period

1.5 years

First QC Date

February 9, 2021

Last Update Submit

February 23, 2023

Conditions

Acute WoundTraumatic WoundSkin GraftSkin FlapSubacute WoundDehiscence

Keywords

Negative Pressure Wound TherapyPost Market Clinical Follow-up

Outcome Measures

Primary Outcomes (1)

  • Change in wound progress

    Wound progress compared to last visit and assessed as: * Deteriorated * No change * Improved

    Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

Secondary Outcomes (18)

  • Wound progress

    28 days

  • Wound dimension

    Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

  • Tissue type

    Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

  • Exudate

    Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

  • Peri-wound

    Day 7 (+0/-2 days), Day 14 (+0/-2 days), Day 21 (+0/-2 days), and Day 28 (+0/-2 days)

  • +13 more secondary outcomes

Study Arms (3)

Traumatic wounds

EXPERIMENTAL

Treatment with negative pressure wound therapy.

Device: Avance Solo NPWT System

Subacute wounds (e.g., dehisced wounds)

EXPERIMENTAL

Treatment with negative pressure wound therapy.

Device: Avance Solo NPWT System

Flaps and Grafts

EXPERIMENTAL

Treatment with negative pressure wound therapy.

Device: Avance Solo NPWT System

Interventions

Avance Solo NPWT SystemDEVICE

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

Flaps and GraftsSubacute wounds (e.g., dehisced wounds)Traumatic wounds

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Diensthoofd wondkliniek, UZ Gent

Ghent, 9000, Belgium

Location

AZ Delta

Roeselare, 8800, Belgium

Location

CHU Montpellier

Montpellier, 34090, France

Location

Hôpital Paris St Joseph

Paris, 75014, France

Location

Franziskus-Krankenhaus Berlin

Berlin, 10787, Germany

Location

UNIVERSITÄTSKLINIKUM Schleswig-Holstein Campus Lübeck

Lübeck, D- 23538, Germany

Location

"E. Profili" Civil Hospital

Fabriano, 60044, Italy

Location

Ospedale San Raffaele S.r.l.

Milan, 20132, Italy

Location

A.O.U. Citta della Salute e della Scienza di Torino - A.O.U. Molinette San Giovanni Battista

Torino, 10126, Italy

Location

Università dell'Insubria, Varese

Varese, 21100, Italy

Location

Study Officials

  • Hilde Beele, Prof. Dr.

    University Hospital, Ghent

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Three different patient groups treated with the Avance Solo NPWT System
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2021

First Posted

February 15, 2021

Study Start

June 15, 2021

Primary Completion

December 6, 2022

Study Completion

December 6, 2022

Last Updated

February 24, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

DE(2)BE(2)FR(2)IT(4)