Ignite Creation Date:
2024-05-06 @ 3:47 PM
Last Modification Date:
2024-10-26 @ 1:57 PM
Study NCT ID:
NCT04754048
Status:
COMPLETED
Last Update Posted:
2023-02-24
First Post:
2021-02-09
Brief Title:
Confirm the Safety and Performance of Avance Solo NPWT System
Sponsor:
Molnlycke Health Care AB
Organization:
Molnlycke Health Care AB
Study Overview
Official Title:
A Prospective Open Non-comparative Post-market Clinical Follow-up Investigation to Confirm Safety and Performance of Avance Solo NPWT System in Low to Moderate Exuding Acute Traumatic Wounds and Flaps and Grafts as Well as Subacute eg Dehisced Wounds Wounds
Status:
COMPLETED
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ASOLO-SW
Brief Summary:
The primary objective of this post market clinical follow-up PMCF investigation is to confirm safety and performance of Avance Solo NPWT System in low to moderate exuding acute traumatic wounds and flaps and grafts as well as subacute eg dehisced wounds 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 non-comparative PMCF investigation to confirm safety and performance of Avance Solo NPWT System in subjects with traumatic wounds n34 subacute eg dehisced wounds wounds n34 and flaps and grafts n34 This is a multi-center study that will take place in approximately 5 European countries The eligible subjects will be both in and out patients and all will be treated with Avance Solo NPWT System for up to 28 days
Treatment will be stopped if the wound is considered healed has a high enough percentage of graft take or enough flap viability by the judgement of the clinicians before the complete treatment time 28 days
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 be assessed at each follow-up visit and measured by three outcomes
Deteriorated
No change
Improved
Treatment will be stopped if the wound is considered healed has a high enough percentage of graft take or enough flap viability by the judgement of the clinicians before the complete treatment time 28 days
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 be assessed at each follow-up visit and measured by three outcomes
Deteriorated
No change
Improved
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None