NCT04753294

Confirm Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems

A Prospective, Open, Non-comparative, Post-market Clinical Follow-up Investigation to Confirm the Safety and Performance of Avance Solo and Avance Solo Adapt NPWT Systems in Low to Moderate Exuding Chronic Wounds

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: Molnlycke Health Care AB · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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

Conditions

• Venous Leg Ulcer
• Pressure Ulcer
• Diabetic Foot Ulcer
• Chronic Ulcer

Interventions

Type	Name	Description
DEVICE	Avance Solo NPWT System	Wound treatment with Avance Solo NPWT System for up to 28 days.
DEVICE	Avance Solo Adapt NPWT System	Wound treatment with Avance Solo Adapt NPWT System for up to 28 days.

Timeline

• Start date: 2021-06-14
• Primary completion: 2023-07-15
• Completion: 2023-07-21
• First posted: 2021-02-15
• Last updated: 2023-09-08

Locations

13 sites across 7 countries: Belgium, Denmark, France, Germany, Ireland, Italy, Portugal