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.
Study Type
OBSERVATIONAL
Enrollment
153
* Mucosal sutures in the facial and oral * Dermal sutures, particularly in pediatrics * Episiotomy * Circumcision
Leopoldina-Krankenhaus GmbH
Schweinfurt, Bavaria, Germany
Benedictus Krankenhaus Tutzing GmbH & Co.
Tutzing, Bavaria, Germany
Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology
Frankfurt am Main, Hesse, Germany
Complication
Descriptive Analysis of the Frequency of tissue reaction or inflammation, wound infection, seroma, fistula, abscess formation, hematoma, suture removal or re-suturing at different time points
Time frame: at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)
Complications
Descriptive Analysis of dehiscence rates of the skin needing surgical treatment with re-closure
Time frame: until day of discharge (approximately 1 week)
Dehiscence
Descriptive Analysis of dehiscence rates of the skin needing surgical treatment with re-closure for two different intervals: time of Intervention until day of discharge as well as day of discharge until follow-up visit at approximately 1-3 months postoperatively
Time frame: until day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)
Patient and Observer Scar Assessment Scale (POSAS)
Effectiveness parameter: Patient and Observer Scar Assessment Scale (POSAS) The POSAS consists of two parts: a Patient Scale and an Observer Scale. Both scales contain six items that are scored numerically and make up a 'Total Score' of the Patient and Observer Scale. Each item of both scales has a 10-point score, with 10 indicating the worst imaginable scar or sensation. The lowest score is '1', and corresponds to the situation of normal skin (normal pigmentation, no itching etc), and goes up to the worst imaginable. The Total Score of both scales can be simply calculated by summing up the scores of each of the six items. The Total Score will therefore range from 6 to 60. Besides the six items the 'Overall Opinion' of the scar quality is scored separately of both patients and observers. \[http://www.posas.org\]
Time frame: at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)
Cosmetic outcome
Effectiveness parameter: Evaluation of the wound using VAS (1 worse - 10 excellent)
Time frame: at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)
Pain
Effectiveness parameter: using the visual analogue scale (VAS 1 - 10) at discharge, and at follow-up visit depending on the routine clinical practice.
Time frame: at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)
Satisfaction of the patient
until day of discharge, and at follow-up visit depending on routine clinical practice using VAS (1 - 10).
Time frame: at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)
Handling of the suture material
Performance Parameter: questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag, stiffness, etc) with 5 evaluations levels (excellent, very good, good, satisfied, poor).
Time frame: intra-operatively
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