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

Completed

• Conditions: Wounds

• Registration Number: NCT06083740
• Lead Sponsor: P.G.F. Industry Solutions GmbH

Brief 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.

Detailed 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

Study Timeline

• Study Start: 2022-11-01
• Primary Completion: 2023-03-01
• Study Completion: 2023-06-01
• Status Verified: 2023-10
• Study First Submitted: 2023-10-09
• Study First Submitted QC: 2023-10-09
• Last Update Submitted: 2023-10-09
• Study First Posted: 2023-10-16
• Last Update Posted: 2023-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluation of safety: • AES: 0,00%, 95% CI: (0,00% - 4,16%) • ADEs: 0,00%, 95% CI: (0,00% - 4,16%)	9 months	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).

Trial Locations

Locations (1)

PGF Industry Solutions GmbH; 🇦🇹 Salzburg, Austria