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Clinical Trial Summary

The ASOLO-SCI investigation is a Post Market Clinical Follow-up (PMCF) study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the Instructions for Use (IfU).


Clinical Trial Description

The ASOLO-SCI investigation is designed as a prospective, open, non-comparative, PMCF study to investigate the safety and performance of the Avance® Solo NPWT System in treating low to moderate exuding surgically closed incisions for up to 14 days when used in accordance with the IfU in up to 34 patients (n=34). The ASOLO-SCI investigation is a multicentre study that is expected to take place in approximately three European centres. The study treatment shall be stopped earlier (i.e. prior to 14 days), in the event study Subjects withdraw their consent, or shall the Principal Investigator and clinical team deem the Avance® Solo NPWT System to be no longer adequate for the study Subject's wound. Following termination of Subject participation for whichever reason in the study, the patient shall be followed in accordance with the local standard of care in wound management and treatment. As a primary endpoint, the Principal Investigator and clinical team will evaluate whether the surgical incision remains closed, from baseline to study end at Day 14. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04894604
Study type Interventional
Source Molnlycke Health Care AB
Contact Alexandre Welikow, MD
Phone 0046317223045
Email alexandre.welikow@molnlycke.com
Status Not yet recruiting
Phase N/A
Start date June 30, 2021
Completion date March 31, 2022

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