Using Novosyn® Quick for closing episiotomy wounds
Observational, Retrospective, Monocentric Clinical Study on the Safety of Novosyn® Quick in Women With a Spontaneous Vaginal Delivery Who Required an Indicated Episiotomy
This study looks at how well Novosyn® Quick works for closing episiotomy wounds in women who had vaginal deliveries.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Aesculap AG Industry-sponsored |
| Locations | 1 site (Sant Cugat Del Vallès, Catalunya) |
| Trial ID | NCT05233527 on ClinicalTrials.gov |
What this trial studies
This observational study analyzes the clinical performance of Novosyn® Quick in women who underwent episiotomy closure at the Hospital General de Catalunya from January to December 2020. The research involves a retrospective review of medical records for women who had spontaneous vaginal deliveries and required an episiotomy. The study aims to evaluate the outcomes associated with the use of Novosyn® Quick in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are women who had an indicated episiotomy during spontaneous vaginal delivery at the Hospital General de Catalunya within the specified timeframe.
Not a fit: Patients who did not undergo an episiotomy or were treated with other closure methods will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the healing process and outcomes for women undergoing episiotomy closure.
How similar studies have performed: While this study focuses on a specific product, similar studies evaluating the effectiveness of different suturing materials in episiotomy closure have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Sant Cugat Del Vallès, Catalunya
- IDC Hospital General de Catalunya — Sant Cugat Del Vallès, Catalunya, Spain (Recruiting)
Study contacts
- Study coordinator: Jaume García López
- Email: info@bbraun.com
- Phone: +34935866200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.