Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery, Pediatric and Adult: Skin Closure (Dermal Sutures), Pediatric: Urological Interventions (Circumcision, Phimosis Etc.), Women: Episiotomy
Conditions
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.
Interventions
DEVICEMonosyn® Quick
* Mucosal sutures in the facial and oral * Dermal sutures, particularly in pediatrics * Episiotomy * Circumcision
Sponsors
B.Braun Surgical SA
Aesculap AG
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. \[http://www.posas.org\] |
| 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) |
| Complications | until day of discharge (approximately 1 week) | Descriptive Analysis of dehiscence rates of the skin needing surgical treatment with re-closure |
| 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). |
| 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). |
| 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. |
Countries
Germany
Outcome results
None listed