Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems (ASOLO-CW)

Molnlycke Health Care

Status: Completed

Conditions: Venous Leg Ulcer; Pressure Ulcer; Chronic Ulcer; Diabetic Foot Ulcer

Treatments: Device: Avance Solo Adapt NPWT System; Device: Avance Solo NPWT System

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT04753294

PD-598654

Details and patient eligibility

About

The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt NPWT Systems in low to moderate exuding chronic 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 and non-comparative PMCF investigation to confirm the safety and performance of Avance®Solo and Avance®Solo Adapt in low to moderate exuding chronic wounds. This is a multi-center study that will take place in approximately 5 European countries. The target subjects are male or female, 18 years or older with low to moderate exuding chronic wounds (pressure ulcers (N=68), diabetic foot ulcers (N=34), and venous leg ulcers (N=34)) suitable for NPWT as deemed by the investigator. Two different options of Negative Pressure Wound Therapies (NPWT) will be evaluated through this clinical investigation

A total of 136 subjects will receive treatment with the investigational devices within the intended use according to Instructions for Use (IfU): Group 1: 102 subjects in total, 34 subjects per indication (pressure ulcers, diabetic foot ulcers, and venous leg ulcers) treated with Avance®Solo and Group 2: 34 subjects with pressure ulcers treated with Avance®Solo Adapt. Subjects will be managed and monitored for a maximum of 4 weeks or until withdrawal from investigation for any reason.

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 take into account all aspects of wound characteristics. Wound progression will be assessed by the Investigator at each follow-up visit and measured by three outcomes:

• Deteriorated
• No change
• Improved

Enrollment: 136 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 chronic wounds (diabetic foot ulcers, venous leg ulcers and pressure ulcers for Avance®Solo or pressure ulcers for Avance®Solo Adapt) suitable for NPWT according to the investigator´s judgement and Instructions for Use.
4. Subjects that will be capable and willing to comply with protocol instructions

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. Known allergy/hypersensitivity to the dressing or its components.
8. Known pregnancy or planning to become pregnant or lactation at time of study participation.
9. Participation in another investigative drug or device trial currently or within the last 30 days Subjects not suitable for the investigation according to the Investigator's judgement, Clinical Investigation Plan and Instructions for Use

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Avance Solo NPWT System

Experimental group

Description:

Treatment with negative pressure wound therapy for Venous leg ulcers, Diabetic foot ulcers, and Pressure ulcers.

Treatment:

Device: Avance Solo NPWT System

Avance Solo Adapt NPWT System

Experimental group

Description:

Treatment with negative pressure wound therapy for Pressure ulcers.

Treatment:

Device: Avance Solo Adapt NPWT System