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

Completed

• Conditions: Episiotomy
• Interventions: Device: Novosyn® Quick

• Registration Number: NCT02762357
• Lead Sponsor: Aesculap AG

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Study Start: 2016-09
• Primary Completion: 2019-10-07
• Study Completion: 2020-01-07
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-08
• Last Update Posted: 2020-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 46

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Novosyn® Quick	Novosyn® Quick	episiotomy closure using suture material

Primary Outcome Measures

Name	Time	Method
Incidence of wound dehiscence	3 months postpartum	A dehiscence of the skin which needs surgical treatment with re-closure.

Secondary Outcome Measures

Name	Time	Method
Incidence of Re-suturing	3 months postpartum	Re-suturing due to wound dehiscence
Dyspareunia	3 months post-operatively	Questionnaire
Incidence of suture removal	3 months postpartum	Suture removal due to wound problems (infection, gaping wound, residual material requiring removal)
Short-term perineal pain (VAS)	24h to 48h, 10 days postpartum
Long term perineal pain (VAS)	3 months postpartum
Pain in daily living (VAS)	24h and 10 days postpartum	Pain in repose, during walking, during sitting, when urinating, and when defecating
Patient satisfaction with the repair (VAS)	until 3 months postpartum
Sexual intercourse	3 months post-operatively	Questionnaire

Trial Locations

Locations (2)

IDC Hospital General de Catalunya; 🇪🇸 Sant Cugat del Vallés, Spain

Hospital General de Granollers; 🇪🇸 Granollers, Spain