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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02762357
Other study ID # AAG-O-H-1504
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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