PMCF-study Using Novosyn® Quick Suture Material for Skin Closure

NCT ID: NCT02680886

Last Updated: 2018-05-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-03-31

Study Completion Date

2018-01-31

Brief Summary

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The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for skin closure. 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.

Detailed Description

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Conditions

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Skin Closure

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Novosyn® Quick

Skin closure using rapid absorbable suture material

Novosyn® Quick

Intervention Type DEVICE

Skin closure

Interventions

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Novosyn® Quick

Skin closure

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pediatric and adult patients undergoing skin closure
* Small linear minimally contaminated incision / lacerations on the trunk or extremities
* Written informed consent

Exclusion Criteria

* Emergency surgery
* Facial lacerations or incisions
* Visible dirt in the wounds
* Nonlinear shape
* Patients taking medical consumption that might affect wound healing
Minimum Eligible Age

1 Year

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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B.Braun Surgical SA

INDUSTRY

Sponsor Role collaborator

Aesculap AG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hospital Saint Louis

La Rochelle, , France

Site Status

Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology

Frankfurt am Main, , Germany

Site Status

Countries

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France Germany

References

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Gfroerer S, Baumann P, Schwalbach AK, Smirnoff A. Prospective international multicenter observational study of Novosyn(R) Quick for skin closures in adults and children (SKINNOQ). BMC Surg. 2019 May 2;19(1):47. doi: 10.1186/s12893-019-0506-8.

Reference Type DERIVED
PMID: 31046730 (View on PubMed)

Other Identifiers

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AAG-O-H-1505

Identifier Type: -

Identifier Source: org_study_id

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