Prospective, International Monosyn® Quick - Non Interventional Study
- Conditions
- Pediatric and Adult: Mucosal Closure in Facial and Oral SurgeryPediatric: Urological Interventions (Circumcision, Phimosis Etc.)Pediatric and Adult: Skin Closure (Dermal Sutures)Women: Episiotomy
- Interventions
- Device: Monosyn® Quick
- Registration Number
- NCT03355001
- Lead Sponsor
- Aesculap AG
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 153
- 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)
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Skin Closure Monosyn® Quick 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. Urology Monosyn® Quick 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. Gynecology Monosyn® Quick 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.
- Primary Outcome Measures
Name Time Method Complication at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively) 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
- Secondary Outcome Measures
Name Time Method Patient and Observer Scar Assessment Scale (POSAS) at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively) 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. \[http://www.posas.org\]
Complications until day of discharge (approximately 1 week) Descriptive Analysis of dehiscence rates of the skin needing surgical treatment with re-closure
Dehiscence until day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively) 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
Handling of the suture material intra-operatively 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).
Cosmetic outcome at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively) Effectiveness parameter: Evaluation of the wound using VAS (1 worse - 10 excellent)
Pain at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively) Effectiveness parameter: using the visual analogue scale (VAS 1 - 10) at discharge, and at follow-up visit depending on the routine clinical practice.
Satisfaction of the patient at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively) until day of discharge, and at follow-up visit depending on routine clinical practice using VAS (1 - 10).
Trial Locations
- Locations (3)
Benedictus Krankenhaus Tutzing GmbH & Co.
🇩🇪Tutzing, Bayern, Germany
Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology
🇩🇪Frankfurt am Main, Hessen, Germany
Leopoldina-Krankenhaus GmbH
🇩🇪Schweinfurt, Bayern, Germany