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

Study Overview
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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.

Official Title
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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.

Conditions
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Episiotomy

Intervention / Treatment
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* Device: Novosyn® Quick


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Novosyn® Quick<br>episiotomy closure using suture material | Device: Novosyn® Quick<br>* Episiotomy closure<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Novosyn Quick, Episiotomy