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PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy

NCT02762357 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 46

Last updated 2020-07-09

No results posted yet for this study

Summary

The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for episiotomy. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature. Study population consists of women with a spontaneous vaginal delivery who required perineal repair due to an episiotomy.

Conditions

  • Episiotomy

Interventions

DEVICE

Novosyn® Quick

Episiotomy closure

Sponsors & Collaborators

  • B.Braun Surgical SA

    collaborator INDUSTRY

  • Aesculap AG

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-09-30
Primary Completion
2019-10-07
Completion
2020-01-07

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02762357 on ClinicalTrials.gov