Prospective, International Monosyn® Quick

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

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-03

Study Completion Date

2019-09-21

Brief Summary

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The Monosyn® Quick non-interventional study (NIS) has been designed to implement an action within the framework of a proactive post-market surveillance system.

The aim of this NIS is to collect systematically and proactively different clinical parameters regarding safety, effectiveness and performance of Monosyn® Quick suture material under the daily clinical practice when used as intended.

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Detailed Description

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Conditions

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Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery Pediatric and Adult: Skin Closure (Dermal Sutures) Women: Episiotomy Pediatric: Urological Interventions (Circumcision, Phimosis Etc.)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Skin Closure

Monosyn® Quick will be used for skin closure for the adaptation of soft tissue and mucous membranes, when wound support over a period of 7 days is considered adequate.

Monosyn® Quick

Intervention Type DEVICE

* Mucosal sutures in the facial and oral
* Dermal sutures, particularly in pediatrics
* Episiotomy
* Circumcision

Urology

Monosyn® Quick will be used in urology for the adaptation of soft tissue and mucous membranes, when wound support over a period of 7 days is considered adequate.

Monosyn® Quick

Intervention Type DEVICE

* Mucosal sutures in the facial and oral
* Dermal sutures, particularly in pediatrics
* Episiotomy
* Circumcision

Gynecology

Monosyn® Quick will be used in gynecology for the adaptation of soft tissue and mucous membranes, when wound support over a period of 7 days is considered adequate.

Monosyn® Quick

Intervention Type DEVICE

* Mucosal sutures in the facial and oral
* Dermal sutures, particularly in pediatrics
* Episiotomy
* Circumcision

Interventions

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Monosyn® Quick

* Mucosal sutures in the facial and oral
* Dermal sutures, particularly in pediatrics
* Episiotomy
* Circumcision

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Pediatric and adult patients undergoing mucosal wound or skin closure using Monosyn® Quick as suture material or women undergoing an episiotomy or pediatric patients undergoing an urological intervention such as a circumcision or phimosis or hypospadias etc.
* Written informed regarding the data collection for the Post Market Clinical Follow-Up (PMCF)