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

Episiotomy Clinical Trial

— EPINOQ  

Official title:

Post-Marketing Clinical Follow-up (PMCF) Study to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material for Episiotomy . A Monocenter, Prospective, Observational Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02762357
• Other study ID #: AAG-O-H-1504
• Status: Completed
• Start date: September 2016
• Est. completion date: January 7, 2020

Study information

• Verified date: July 2020
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 7, 2020
• Est. primary completion date: October 7, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Episiotomy

Intervention

Device:
• Novosyn® Quick
Episiotomy closure

Locations

Country	Name	City	State
Spain	Hospital General de Granollers	Granollers
Spain	IDC Hospital General de Catalunya	Sant Cugat del Vallés

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of wound dehiscence	A dehiscence of the skin which needs surgical treatment with re-closure.	3 months postpartum
Secondary	Incidence of Re-suturing	Re-suturing due to wound dehiscence	3 months postpartum
Secondary	Incidence of suture removal	Suture removal due to wound problems (infection, gaping wound, residual material requiring removal)	3 months postpartum
Secondary	Short-term perineal pain (VAS)		24h to 48h, 10 days postpartum
Secondary	Long term perineal pain (VAS)		3 months postpartum
Secondary	Pain in daily living (VAS)	Pain in repose, during walking, during sitting, when urinating, and when defecating	24h and 10 days postpartum
Secondary	Dyspareunia	Questionnaire	3 months post-operatively
Secondary	Sexual intercourse	Questionnaire	3 months post-operatively
Secondary	Patient satisfaction with the repair (VAS)		until 3 months postpartum