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

  • STATUS
    Recruiting
  • End date
    Mar 21, 2022
  • participants needed
    136
  • sponsor
    Molnlycke Health Care AB
Updated on 20 July 2021
diabetic foot

Summary

The primary objective of this post market clinical follow-up (PMCF) investigation is to confirm the safety and performance of AvanceSolo and AvanceSolo Adapt NPWT Systems in low to moderate exuding chronic wounds when used in accordance with the Instructions for Use, for up to 28 days.

Description

This investigation is designed as a prospective, open and non-comparative PMCF investigation to confirm the safety and performance of AvanceSolo and AvanceSolo 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 AvanceSolo and Group 2: 34 subjects with pressure ulcers treated with AvanceSolo 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

Details
Condition Varicose Ulcer, Venous stasis, Decubitus Ulcer, Diabetic Foot, Diabetic Foot Ulcers, Pressure Ulcers, Pressure Ulcer, Chronic Ulcer, diabetic foot ulcer, venous ulcers, venous ulcer, pressure sores, decubitus, bedsore
Treatment Avance Solo NPWT System, Avance Solo Adapt NPWT System
Clinical Study IdentifierNCT04753294
SponsorMolnlycke Health Care AB
Last Modified on20 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Male or female 18 years
Signed written informed consent
Low to moderate exuding chronic wounds (diabetic foot ulcers, venous leg ulcers and pressure ulcers for AvanceSolo or pressure ulcers for AvanceSolo Adapt) suitable for NPWT according to the investigators judgement and Instructions for Use
Subjects that will be capable and willing to comply with protocol instructions

Exclusion Criteria

Known malignancy in the wound or margins of the wound
Untreated and previously confirmed osteomyelitis
Non-enteric and unexplored fistulas
Necrotic tissue with eschar present
Exposed nerves, arteries, veins or organs
Exposed anastomotic site
Known allergy/hypersensitivity to the dressing or its components
Known pregnancy or planning to become pregnant or lactation at time of study participation
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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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