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OpenTrials
Completed

NCT Number: NCT06083740

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.

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Key information

Conditions

Wounds Burns Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

PGF Industry Solutions GmbH

Salzburg, Austria

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Granudacyn/Veriforte

Device

Wound irrigation solution for all kinds of wounds (Acute, chronic or contaminated wounds).

Primary outcomes

  1. Evaluation of safety: • AES: 0,00%, 95% CI: (0,00% - 4,16%) • ADEs: 0,00%, 95% CI: (0,00% - 4,16%)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

P.G.F. Industry Solutions GmbH

Industry

Collaborators

  • WPM - Wund Pflege Management Ges.m.b.H

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 16, 2023
Registry last updated
Oct 16, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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