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

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

46 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-09-30

Study Completion Date

2020-01-07

Brief Summary

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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.

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Detailed Description

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Conditions

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Episiotomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Novosyn® Quick

episiotomy closure using suture material

Novosyn® Quick

Intervention Type DEVICE

Episiotomy closure

Interventions

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Novosyn® Quick

Episiotomy closure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Primiparous women who require perineal repair due to an episiotomy after spontaneous vaginal delivery.
* Singleton birth between 37 and 42 weeks gestation
* Written informed consent

Exclusion Criteria

* Age\< 18 years
* Previous perineal surgery
* Instrumental vaginal deliveries
* Multiparous (at least 1 previous perineal delivery)
* Episiotomy involving the anal sphincter or the rectum
* Medical consumption that might adversely affect healing
* Women with active infection at the time of delivery

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No