NCT05233527

Brief Summary

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

Trial Health

75
On Track

Trial Health Score

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

Enrollment
229

participants targeted

Target at P75+ for all trials

Timeline
5mo left

Started May 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
May 2024Oct 2026

First Submitted

Initial submission to the registry

January 26, 2022

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 10, 2022

Completed
2.2 years until next milestone

Study Start

First participant enrolled

May 9, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2026

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

April 17, 2026

Status Verified

April 1, 2026

Enrollment Period

1.9 years

First QC Date

January 26, 2022

Last Update Submit

April 15, 2026

Conditions

Episiotomy Wound

Outcome Measures

Primary Outcomes (1)

  • Wound dehiscence rate

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

    up to 1 month postpartum

Secondary Outcomes (11)

  • Rate of Re-suturing

    up to 1 month postpartum

  • Rate of Suture removal due to wound problems

    up to 1 month postpartum

  • Surgical Site Infection rate

    up to 1 month postpartum

  • Bleeding

    up to 1 month postpartum

  • Hematoma

    up to 1 month postpartum

  • +6 more secondary outcomes

Interventions

Episiotomy ClosurePROCEDURE

indicated episiotomy with Novosyn® Quick after spontaneous vaginal delivery

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IDC Hospital General de Catalunya

Sant Cugat del Vallès, Catalonia, 08190, Spain

Location

Study Design

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

Study Record Dates

First Submitted

January 26, 2022

First Posted

February 10, 2022

Study Start

May 9, 2024

Primary Completion

March 26, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

April 17, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)