NCT02762357

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2016

Typical duration for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

September 1, 2016

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 7, 2019

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 7, 2020

Completed
Last Updated

July 9, 2020

Status Verified

July 1, 2020

Enrollment Period

3.1 years

First QC Date

May 3, 2016

Last Update Submit

July 8, 2020

Conditions

Episiotomy

Keywords

Novosyn QuickEpisiotomy

Outcome Measures

Primary Outcomes (1)

  • Incidence of wound dehiscence

    A dehiscence of the skin which needs surgical treatment with re-closure.

    3 months postpartum

Secondary Outcomes (8)

  • Incidence of Re-suturing

    3 months postpartum

  • Incidence of suture 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)

    24h and 10 days postpartum

  • +3 more secondary outcomes

Study Arms (1)

Novosyn® Quick

episiotomy closure using suture material

Device: Novosyn® Quick

Interventions

Novosyn® QuickDEVICE

Episiotomy closure

Novosyn® Quick

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

adult patients

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hospital General de Granollers

Granollers, 08402, Spain

Location

IDC Hospital General de Catalunya

Sant Cugat Del Vallés, 08190, Spain

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 4, 2016

Study Start

September 1, 2016

Primary Completion

October 7, 2019

Study Completion

January 7, 2020

Last Updated

July 9, 2020

Record last verified: 2020-07

Data Sharing

IPD Sharing
Will not share

Locations

ES(2)