Novosyn® Quick in Patients Undergoing Episiotomy Closure (RETRO-EPINOQ)

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

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

Study Overview

• Status: Active, not recruiting
• Conditions: Episiotomy Wound
• Intervention / Treatment: Procedure: Episiotomy Closure

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 229

Contacts and Locations

Study Locations

• Spain
  • Catalonia
    • Sant Cugat del Vallès, Catalonia, Spain, 08190
      • IDC Hospital General de Catalunya

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound dehiscence rate	A dehiscence of the wound which needs surgical treatment with re-closure.	up to 1 month postpartum

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Re-suturing	Number of patients requiring a re-suturing due to wound dehiscence	up to 1 month postpartum
Rate of Suture removal due to wound problems	Number of patients requiring suture removal due to wound problems (infection, gaping wound, residual material requiring removal)	up to 1 month postpartum
Surgical Site Infection rate	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).	up to 1 month postpartum
Bleeding	Incidence of Bleeding after Episiotomy closure	up to 1 month postpartum
Hematoma	Incidence of Hematoma after Episiotomy closure	up to 1 month postpartum
Abscess formation	Incidence of Abscess formation after Episiotomy closure	up to 1 month postpartum
Rectovaginal fistula	Incidence of Rectovaginal fistula after Episiotomy closure	up to 1 month postpartum
Short-term perineal pain (VAS)	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".	after 48 hours postpartum
Long-term perineal pain (VAS)	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".	up to 1 month postpartum
Short-term Pain in daily living (VAS)	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	24-48 hours postpartum
Long-term Pain in daily living (VAS)	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	up to 1 month postpartum

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA

Study record dates

Study Major Dates

• Study Start (Actual): May 9, 2024
• Primary Completion (Actual): March 26, 2026
• Study Completion (Estimated): October 1, 2026

Study Registration Dates

• First Submitted: January 26, 2022
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 10, 2022

Study Record Updates

• Last Update Posted (Actual): April 17, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: AAG-O-H-2111

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No