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

Sponsor
P.G.F. Industry Solutions GmbH (Industry)
Overall Status
Completed
CT.gov ID
NCT06083740
Collaborator
WPM - Wund Pflege Management Ges.m.b.H (Other)
104
Enrollment
1
Location
7
Actual Duration (Months)
14.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
104 participants
Observational Model:
Cohort
Time Perspective:
Retrospective
Official Title:
A Postmarket Clinical Follow Up Study (PMCF) to Evaluate the Safety and Performance of VERIFORTE/Granudacyn® Med Wound Irrigation Solution.
Actual Study Start Date :
Nov 1, 2022
Actual Primary Completion Date :
Mar 1, 2023
Actual Study Completion Date :
Jun 1, 2023

Outcome Measures

Primary Outcome Measures

  1. 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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 PGF Industry Solutions GmbH Salzburg Austria

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
P.G.F. Industry Solutions GmbH
ClinicalTrials.gov Identifier:
NCT06083740
Other Study ID Numbers:
  • CIP_WSL_2022_001
First Posted:
Oct 16, 2023
Last Update Posted:
Oct 16, 2023
Last Verified:
Oct 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by P.G.F. Industry Solutions GmbH
Acute wounds, chronic wounds, burns
Additional relevant MeSH terms:
Wounds and Injuries

Study Results

No Results Posted as of Oct 16, 2023