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

NCT06083740 | Completed DMC

• 1 other identifier: CIP_WSL_2022_001
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Wounds

Keywords

Acute wounds, chronic wounds, burns

Outcome Measures

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).

  9 months

Interventions

Granudacyn/Veriforte DEVICE

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Vulnerable persons

Sponsors & Collaborators

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

Study Sites (1)

PGF Industry Solutions GmbH

Salzburg, Austria

Location

MeSH Terms

Conditions

Wounds and Injuries; Burns

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: October 16, 2023
• Study Start: November 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: June 1, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)