CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 41 enrolled
Drug / intervention
Not specified
Likely dose
Not stated in record
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Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04507724
NCT04507724N/ACompleted

The Use of Biochemical Analyzes to Monitor the Development of Wounds: Part 1: Analysis of Wounds Without VAC Therapy: Part 2: Analysis of Wound Fluids Under VAC Therapy

Qualizyme Diagnostics GmbH & Co KG·observational·Posted Aug 11, 2020·Updated May 18, 2021

In Brief

An observational study for Wound and 5 related conditions. Completed, enrolled 41 participants across 1 site.

Detailed Summary

Chronic wounds represent a growing challenge in medical care. Part 1: The aim of this part of the study was to collect wound swabs and to answer the question whether the rapid diagnostic tool using enzyme activities can display an infection prematurely. This means that an increased enzyme activity (especially MPO, NHE, LYS, gelatinase, pH) measured overed 3 days, would indicate a change in the wound bed (infection, Inflammation) earlier than the regularly performed clinical assessment. Part 2: The aim of this part of the study was to evaluate (I) the possibility of wound fluid acquisition by means of an "additional collector" during ongoing NPWT and to answer if (II) this secretion can be biochemically analyzed for enzyme activities in order to be able to detect a change in the wound situation at an early stage.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesAustria
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedAug 11, 2020
Enrollment StartOct 19, 2018
Primary CompletionDec 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 5.9 years ago