Clinical trial NCT03355001: Prospective, International Monosyn® Quick - Non Interventional Study
Official title: Assessment of the Performance of Monosyn® Quick Suture Material in Different Indications Under Daily Clinical Routine.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: 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.)
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2017-11-28
Enrollment: 153
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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 as a circumcision or phimosis or hypospadias

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Complication
timeFrame: at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)
Secondary outcomes:
measure: Complications
timeFrame: until day of discharge (approximately 1 week)
measure: Dehiscence
timeFrame: until day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)
measure: Patient and Observer Scar Assessment Scale (POSAS)
timeFrame: at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)
measure: Cosmetic outcome
timeFrame: at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)
measure: Pain
timeFrame: at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)
measure: Satisfaction of the patient
timeFrame: at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)
measure: Handling of the suture material
timeFrame: intra-operatively
Other outcomes:
Locations:
city: Schweinfurt
country: Germany
facility: Leopoldina-Krankenhaus GmbH
state: Bayern
city: Tutzing
country: Germany
facility: Benedictus Krankenhaus Tutzing GmbH & Co.
state: Bayern
city: Frankfurt am Main
country: Germany
facility: Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology
state: Hessen
Study officials:
References:
citation: Baumann P, Gumpinger F. Prospective, Observational Study to Assess a New Quick Absorbable Monofilament Suture for Skin Closure in Adults. Journal of Surgery 2021; 9(2):63.
citation: Baumann P, Weigel M. Episiotomy Closure After Vaginal Delivery-A Prospective, Single Centre Study Assessing a Novel Fast-Absorbable, Monofilament Suture in Daily Practice. Journal of Surgery 2021; 9(3):121.