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NCT Number: NCT05233527

Novosyn® Quick in Patients Undergoing Episiotomy Closure

Retrospective, monocentric clinical study on the clinical performance of Novosyn® Quick in patients undergoing episiotomy closure.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Episiotomy Wound

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

IDC Hospital General de Catalunya

Sant Cugat del Vallès, Catalonia, 08190, Spain

About this study

The study design is a retrospective, consecutive series of women with a spontaneous vaginal delivery who required an indicated episiotomy with Novosyn® Quick between the period January 2020 - December 2020 at Hospital General de Catalunya.

All women treated with Novosyn® Quick between January 2020 - December 2020 at the Hospital General de Catalunya will be analyzed. The investigator team will access medical records for the cohort of patients identified.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Women who underwent an indicated episiotomy between January 2020 - December 2020 at the Hospital General de Catalunya (Sant Cugat del Vallès, Spain) and received Novosyn® Quick

Exclusion criteria

  • No exclusion criteria have been set

Treatment and study plan

Episiotomy Closure

Procedure

indicated episiotomy with Novosyn® Quick after spontaneous vaginal delivery

Primary outcomes

  1. Wound dehiscence rate

    Time frame: up to 1 month postpartum

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

Secondary outcomes

  1. Rate of Re-suturing

    Time frame: up to 1 month postpartum

    Number of patients requiring a re-suturing due to wound dehiscence

  2. Rate of Suture removal due to wound problems

    Time frame: up to 1 month postpartum

    Number of patients requiring suture removal due to wound problems (infection, gaping wound, residual material requiring removal)

  3. Surgical Site Infection rate

    Time frame: up to 1 month postpartum

    A surgical site infection is an infection that occurs after surgery in the part of the body where the surgery took place. Surgical site infections can sometimes be superficial infections (A1) involving the skin only. Other surgical site infections are more serious and can involve tissues under the skin, organs, or implanted material (A2).

  4. Bleeding

    Time frame: up to 1 month postpartum

    Incidence of Bleeding after Episiotomy closure

  5. Hematoma

    Time frame: up to 1 month postpartum

    Incidence of Hematoma after Episiotomy closure

  6. Abscess formation

    Time frame: up to 1 month postpartum

    Incidence of Abscess formation after Episiotomy closure

  7. Rectovaginal fistula

    Time frame: up to 1 month postpartum

    Incidence of Rectovaginal fistula after Episiotomy closure

  8. Short-term perineal pain (VAS)

    Time frame: after 48 hours postpartum

    This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".

  9. Long-term perineal pain (VAS)

    Time frame: up to 1 month postpartum

    This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".

  10. Short-term Pain in daily living (VAS)

    Time frame: 24-48 hours postpartum

    This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".in repose, during walking, during sitting, when urinating, and when defecating

  11. Long-term Pain in daily living (VAS)

    Time frame: up to 1 month postpartum

    This parameter will be noted using the Visual Analogue Scale (VAS) which state "0" at one end representing "no pain" and "100" at the opposite end representing "heavy pain".in repose, during walking, during sitting, when urinating, and when defecating

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

Observational, Retrospective, Monocentric Clinical Study on the Safety of Novosyn® Quick in Women With a Spontaneous Vaginal Delivery Who Required an Indicated Episiotomy

Acronym: RETRO-EPINOQ

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Feb 10, 2022
Registry last updated
Apr 17, 2026

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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