Status:
UNKNOWN
A Safety and Performance PMCF Investigation of the Avance® Solo NPWT System in Surgically Closed Incisions
Lead Sponsor:
Molnlycke Health Care AB
Collaborating Sponsors:
Syntactx
Conditions:
Incision, Surgical
Surgical Incision
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 cl...
Detailed 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 exudin...
Eligibility Criteria
Inclusion
- Inclusion criteria:
- Male or female ≥ 18 years of age.
- Signed written Informed Consent Form.
- Low to moderate exuding surgically closed incisions suitable for suNPWT, according with the Investigator´s judgement and the Avance® Solo NPWT System Instructions for Use.
- Study subjects that are deemed capable and willing to comply with the 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 breastfeeding 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.
Exclusion
Key Trial Info
Start Date :
June 30 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2022
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT04894604
Start Date
June 30 2021
End Date
March 31 2022
Last Update
May 20 2021
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