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

P.G.F. Industry Solutions

Status: Completed

Conditions: Wounds

Treatments: Device: Granudacyn/Veriforte

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT06083740

CIP_WSL_2022_001

Details and patient eligibility

About

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.

Full 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

Enrollment: 104 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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