CClinicalTrials.gg
CompletedNCT06083740Updated Oct 16, 2023

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

An observational study in Wounds, sponsored by P.G.F. Industry Solutions GmbH. Completed at 1 site in Austria. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-10-16.

Sponsored by P.G.F. Industry Solutions GmbH · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
104
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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
02

Conditions studied

  • Wounds

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Keywords

  • Acute wounds, chronic wounds, burns
03

In context

Wounds and Injuries

5,056 studies on the registry are indexed under Wounds and Injuries; 861 are open to participants now.

This study's enrollment of 104 is below the median of 135 across 1,597 observational studies indexed under Wounds and Injuries.

Browse Wounds and Injuries studies →

Lead sponsor

This is the only study on the registry with P.G.F. Industry Solutions GmbH as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

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

Exclusion Criteria:

  • Vulnerable persons
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
104 participants (actual)
Patient registry
No

Interventions

  • DeviceGranudacyn/Veriforte

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

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 9 months

07

Study locations

1 site
  • PGF Industry Solutions GmbH
    Salzburg, Austria
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06083740
Lead sponsor
P.G.F. Industry Solutions GmbH
Collaborators
WPM - Wund Pflege Management Ges.m.b.H
Responsible party
Sponsor
First posted
Oct 16, 2023
Start date
Nov 1, 2022
Primary completion
Mar 1, 2023
Completion
Jun 1, 2023
Last update
Oct 16, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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