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

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.

Study Overview

• Status: Completed
• Conditions: Wounds
• Intervention / Treatment: Device: Granudacyn/Veriforte

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 Type: Observational
• Enrollment (Actual): 104

Contacts and Locations

Study Locations

• Austria
  • Salzburg, Austria
    • PGF Industry Solutions GmbH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

One treatment group (single-arm): All subjects participating in the study will be treated with Granudacyn/VERIFORTE med wound irrigation solution. People with a completed treatment of an acute or chronic wound participated in the study.

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: P.G.F. Industry Solutions GmbH
• Collaborators: WPM - Wund Pflege Management Ges.m.b.H

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Actual): March 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: October 9, 2023
• First Submitted That Met QC Criteria: October 9, 2023
• First Posted (Actual): October 16, 2023

Study Record Updates

• Last Update Posted (Actual): October 16, 2023
• Last Update Submitted That Met QC Criteria: October 9, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Acute wounds, chronic wounds, burns
• Additional Relevant MeSH Terms: Wounds and Injuries
• Other Study ID Numbers: CIP_WSL_2022_001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No