Status:
COMPLETED
Confirm the Safety and Performance of Avance Solo NPWT System
Lead Sponsor:
Molnlycke Health Care AB
Collaborating Sponsors:
Syntactx
Conditions:
Acute Wound
Traumatic Wound
Eligibility:
All Genders
18+ years
Phase:
NA
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 an...
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 (n=34), subacu...
Eligibility Criteria
Inclusion
- Male or female ≥ 18 years.
- Signed written informed consent.
- Low to moderate exuding acute (traumatic wound, or a flap/graft) or subacute (e.g., dehisced wounds) wounds suitable for single use NPWT according to the investigator´s judgement and Instructions for Use
Exclusion
- 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
- Subjects with known allergies/hypersensitivity to product components.
- Known pregnancy or planning to become pregnant or lactation at the time of study participation.
- Subjects not suitable for the investigation according to the investigator's judgement and Clinical Investigation Plan and IFU.
- Participating in other ongoing clinical investigation, or during the past 30 days that may impact the outcome of this investigation based on the judgement of the investigator.
Key Trial Info
Start Date :
June 15 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2022
Estimated Enrollment :
105 Patients enrolled
Trial Details
Trial ID
NCT04754048
Start Date
June 15 2021
End Date
December 6 2022
Last Update
February 24 2023
Active Locations (10)
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1
Diensthoofd wondkliniek, UZ Gent
Ghent, Belgium, 9000
2
AZ Delta
Roeselare, Belgium, 8800
3
CHU Montpellier
Montpellier, France, 34090
4
Hôpital Paris St Joseph
Paris, France, 75014