Prospective, International Monosyn® Quick - Non Interventional Study (PRIMOQ)

Aesculap

Status: Completed

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

Treatments: Device: Monosyn® Quick

Study type: Observational

Funder types: Industry

Identifiers

NCT03355001

AAG-O-H-1635

Details and patient eligibility

About

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.

Enrollment: 153 patients

Sex: All

Volunteers: No Healthy Volunteers

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)

Exclusion criteria

• None

Trial design

153 participants in 3 patient groups

Skin Closure

Description:

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.

Treatment:

Device: Monosyn® Quick

Urology

Description:

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.

Treatment:

Device: Monosyn® Quick

Gynecology

Description:

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.

Treatment:

Device: Monosyn® Quick