PMCF-study Using Novosyn® Quick Suture Material for Perin... | NCT02762357

Studies
PMCF-study Using Novosyn® Quick Suture Material for Perineal Repair After Episiotomy

NCT02762357

Sponsor

Aesculap AG

Status

Completed

Last Update Posted

Jul 9, 2020Actual

Enrollment

46Actual

Phase

Not provided

Conditions

Episiotomy

Interventions

Novosyn® Quick

Countries

Spain

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2016Actual

Primary Completion Date

Oct 7, 2019Actual

Completion Date

Jan 7, 2020Actual

First Submitted Date

May 3, 2016

First Submission Date that Met QC Criteria

May 3, 2016

First Posted Date

May 4, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 8, 2020

Last Update Posted Date

Jul 9, 2020Actual

Name	Class
B.Braun Surgical SA	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Novosyn® Quick		episiotomy closure using suture material	Device: Novosyn® Quick

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Novosyn® Quick	Device	Episiotomy closure	Novosyn® Quick

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of wound dehiscence	A dehiscence of the skin which needs surgical treatment with re-closure.	3 months postpartum

Secondary Outcomes

Measure	Description	Time Frame
Incidence of Re-suturing	Re-suturing due to wound dehiscence	3 months postpartum
Incidence of suture removal	Suture removal due to wound problems (infection, gaping wound, residual material requiring removal)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Primiparous women who require perineal repair due to an episiotomy after spontaneous vaginal delivery.
Singleton birth between 37 and 42 weeks gestation
Written informed consent

Exclusion Criteria:

Age< 18 years
Previous perineal surgery
Instrumental vaginal deliveries
Multiparous (at least 1 previous perineal delivery)
Episiotomy involving the anal sphincter or the rectum
Medical consumption that might adversely affect healing
Women with active infection at the time of delivery

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

adult patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hospital General de Granollers		Granollers		08402	Spain
IDC Hospital General de Catalunya

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided