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

Aesculap

Status: Completed

Conditions: Episiotomy

Treatments: Device: Novosyn® Quick

Study type: Observational

Funder types: Industry

Identifiers

NCT02762357

AAG-O-H-1504

Details and patient eligibility

About

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.

Enrollment: 46 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

46 participants in 1 patient group

Novosyn® Quick

Description:

episiotomy closure using suture material

Treatment:

Device: Novosyn® Quick