Trials / Completed
CompletedNCT02762357
PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy
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.
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 46 (actual)
- Sponsor
- Aesculap AG · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Novosyn® Quick | Episiotomy closure |
Timeline
- Start date
- 2016-09-01
- Primary completion
- 2019-10-07
- Completion
- 2020-01-07
- First posted
- 2016-05-04
- Last updated
- 2020-07-09
Locations
2 sites across 1 country: Spain
Source: ClinicalTrials.gov record NCT02762357. Inclusion in this directory is not an endorsement.