Confirm the Safety and Performance of Avance Solo NPWT System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

105 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-15

Study Completion Date

2022-12-06

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Acute Wound Traumatic Wound Skin Graft Skin Flap Subacute Wound Dehiscence

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Three different patient groups treated with the Avance Solo NPWT System

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Traumatic wounds

Treatment with negative pressure wound therapy.

Group Type EXPERIMENTAL

Avance Solo NPWT System

Intervention Type DEVICE

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

Subacute wounds (e.g., dehisced wounds)

Treatment with negative pressure wound therapy.

Group Type EXPERIMENTAL

Avance Solo NPWT System

Intervention Type DEVICE

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

Flaps and Grafts

Treatment with negative pressure wound therapy.

Group Type EXPERIMENTAL

Avance Solo NPWT System

Intervention Type DEVICE

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

Interventions

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Avance Solo NPWT System

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

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No