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

July 8, 2020 updated by: Aesculap AG

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.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

46

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Granollers, Spain, 08402
        • Hospital General de Granollers
      • Sant Cugat del Vallés, Spain, 08190
        • IDC Hospital General de Catalunya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

adult patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Novosyn® Quick
episiotomy closure using suture material
Device: Novosyn® Quick
Episiotomy closure

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Collaborators

B.Braun Surgical SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 1, 2016

Primary Completion (ACTUAL)

October 7, 2019

Study Completion (ACTUAL)

January 7, 2020

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (ESTIMATE)

May 4, 2016

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2020

Last Update Submitted That Met QC Criteria

July 8, 2020

Last Verified

July 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • AAG-O-H-1504

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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