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

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.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02762357

Acronym

EPINOQ

Enrollment

Registered

2016-05-04

Start date

2016-09-30

Completion date

2020-01-07

Last updated

2020-07-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Episiotomy

Keywords

Novosyn Quick, Episiotomy

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.

Interventions

DEVICENovosyn® Quick

Episiotomy closure

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
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	—
Incidence of Re-suturing	3 months postpartum	Re-suturing due to wound dehiscence
Dyspareunia	3 months post-operatively	Questionnaire
Sexual intercourse	3 months post-operatively	Questionnaire
Patient satisfaction with the repair (VAS)	until 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

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026