Status:

COMPLETED

Prospective, International Monosyn® Quick - Non Interventional Study

Lead Sponsor:

Aesculap AG

Collaborating Sponsors:

B.Braun Surgical SA

Conditions:

Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery

Pediatric and Adult: Skin Closure (Dermal Sutures)

Eligibility:

All Genders

Brief Summary

The Monosyn® Quick non-interventional study (NIS) has been designed to implement an action within the framework of a proactive post-market surveillance system. The aim of this NIS is to collect syste...

Eligibility Criteria

Inclusion

  • Pediatric and adult patients undergoing mucosal wound or skin closure using Monosyn® Quick as suture material or women undergoing an episiotomy or pediatric patients undergoing an urological intervention such as a circumcision or phimosis or hypospadias etc.
  • Written informed regarding the data collection for the Post Market Clinical Follow-Up (PMCF)

Exclusion

  • \- None

Key Trial Info

Start Date :

January 3 2018

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

September 21 2019

Estimated Enrollment :

153 Patients enrolled

Trial Details

Trial ID

NCT03355001

Start Date

January 3 2018

End Date

September 21 2019

Last Update

January 11 2022

Active Locations (3)

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Page 1 of 1 (3 locations)

1

Leopoldina-Krankenhaus GmbH

Schweinfurt, Bavaria, Germany, 97422

2

Benedictus Krankenhaus Tutzing GmbH & Co.

Tutzing, Bavaria, Germany, 82327

3

Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology

Frankfurt am Main, Hesse, Germany, 60590