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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

104 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-01

Study Completion Date

2023-06-01

Brief Summary

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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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Detailed Description

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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

Conditions

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Wounds

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Interventions

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Granudacyn/Veriforte

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

Intervention Type DEVICE

Eligibility Criteria

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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.