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Completed

NCT Number: NCT02762357

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

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.

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Key information

Conditions

Episiotomy

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Hospital General de Granollers, Granollers, Spain

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Novosyn® Quick

Device

Episiotomy closure

Primary outcomes

  1. Incidence of wound dehiscence

    Time frame: 3 months postpartum

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

Secondary outcomes

  1. Incidence of Re-suturing

    Time frame: 3 months postpartum

    Re-suturing due to wound dehiscence

  2. Incidence of suture removal

    Time frame: 3 months postpartum

    Suture removal due to wound problems (infection, gaping wound, residual material requiring removal)

  3. Short-term perineal pain (VAS)

    Time frame: 24h to 48h, 10 days postpartum

  4. Long term perineal pain (VAS)

    Time frame: 3 months postpartum

  5. Pain in daily living (VAS)

    Time frame: 24h and 10 days postpartum

    Pain in repose, during walking, during sitting, when urinating, and when defecating

  6. Dyspareunia

    Time frame: 3 months post-operatively

    Questionnaire

  7. Sexual intercourse

    Time frame: 3 months post-operatively

    Questionnaire

  8. Patient satisfaction with the repair (VAS)

    Time frame: until 3 months postpartum

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

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.

Acronym: EPINOQ

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
May 4, 2016
Registry last updated
Jul 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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