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

Diabetic Foot Ulcer Clinical Trial

Official title:
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

Clinical Trial 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.

Clinical Trial 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 ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04753294
Study type Interventional
Source Molnlycke Health Care AB
Contact
Status Completed
Phase N/A
Start date June 14, 2021
Completion date July 21, 2023
View Details
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