Confirm the Safety and Performance of Avance Solo NPWT System (ASOLO-SW)

Molnlycke Health Care

Status: Completed

Conditions: Acute Wound; Skin Flap; Dehiscence; Skin Graft; Subacute Wound; Traumatic Wound

Treatments: Device: Avance Solo NPWT System

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04754048

PD-598655

Details and patient eligibility

About

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.

Full 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

Enrollment: 105 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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105 participants in 3 patient groups

Traumatic wounds

Experimental group

Description:

Treatment with negative pressure wound therapy.

Treatment:

Device: Avance Solo NPWT System

Subacute wounds (e.g., dehisced wounds)

Experimental group

Description:

Treatment with negative pressure wound therapy.

Treatment:

Device: Avance Solo NPWT System

Flaps and Grafts

Experimental group

Description:

Treatment with negative pressure wound therapy.

Treatment:

Device: Avance Solo NPWT System