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NCT06083740 Clinical Trial

A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.

Wounds Clinical Trial

Official title:
A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT06083740
Other study ID # CIP_WSL_2022_001
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 1, 2022
Est. completion date June 1, 2023

Study information
Verified date October 2023
Source P.G.F. Industry Solutions GmbH
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

In the course of this clinical trial, it was shown that the use of Granudacyn/VERIFORTE med wound irrigation solution in the course of adjuvant therapy supports wound healing through mechanical irrigation and moistening of the wound. No risks have been reported. The benefits of using Granudacyn/VERIFORTE med wound irrigation solution therefore outweigh the potential risks.

Description:

Aim of this clinical trial was to collect clinical data on the performance and safety of the use of Granudacyn/VERIFORTE med as a wound irrigation solution, for cleansing and irrigation of acute, chronic or contaminated wounds. The evaluation of the safety of the use of Granudacyn/VERIFORTE med wound irrigation solution within the scope of use was based on the frequency of adverse events (AEs) and, in particular, treatment-emergent adverse events (ADEs). Study Design: - Open-label, retrospective, monocentric, PMCF, non-interventional, observational study. - One treatment group (single arm): All subjects participating in the study will be treated with Granudacyn/VERIFORTE med wound irrigation solution. - The study will be conducted in Austria. The participating trial centre is in Lower Austria: WPM Ges.m.b.H

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date June 1, 2023
Est. primary completion date March 1, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Presence of a documented case report within the indication, which enables a retrospective evaluation of the target variables. - Subjects are = 18 years of age. - Gender: All. Exclusion Criteria: - Vulnerable persons

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Granudacyn/Veriforte
Wound irrigation solution for all kinds of wounds (Acute, chronic or contaminated wounds).

Locations
Country Name City State
Austria PGF Industry Solutions GmbH Salzburg

Sponsors (2)
Lead Sponsor Collaborator
P.G.F. Industry Solutions GmbH WPM - Wund Pflege Management Ges.m.b.H

Country where clinical trial is conducted

Austria, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of safety: • AES: 0,00%, 95% CI: (0,00% - 4,16%) • ADEs: 0,00%, 95% CI: (0,00% - 4,16%) Evaluation of the safety of the use of Granudacyn/VERIFORTE med wound irrigation solution within the scope of use, based on the frequency of adverse events (AEs) and, in particular, treatment-emergent adverse events (ADEs). 9 months
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