Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery Clinical Trial
— PRIMOQOfficial title:
Assessment of the Performance of Monosyn® Quick Suture Material in Different Indications Under Daily Clinical Routine.
| Verified date | December 2021 |
| Source | Aesculap AG |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Completed |
| Enrollment | 153 |
| Est. completion date | September 21, 2019 |
| Est. primary completion date | September 18, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| 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 | Benedictus Krankenhaus Tutzing GmbH & Co. | Tutzing | Bayern |
| Lead Sponsor | Collaborator |
|---|---|
| Aesculap AG | B.Braun Surgical SA |
Germany,
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.
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.
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively) | |
| Secondary | Complications | Descriptive Analysis of dehiscence rates of the skin needing surgical treatment with re-closure | until day of discharge (approximately 1 week) | |
| Secondary | 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 | until day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively) | |
| Secondary | 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] | at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively) | |
| Secondary | Cosmetic outcome | Effectiveness parameter: Evaluation of the wound using VAS (1 worse - 10 excellent) | at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively) | |
| Secondary | Pain | Effectiveness parameter: using the visual analogue scale (VAS 1 - 10) at discharge, and at follow-up visit depending on the routine clinical practice. | at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively) | |
| Secondary | Satisfaction of the patient | until day of discharge, and at follow-up visit depending on routine clinical practice using VAS (1 - 10). | at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively) | |
| Secondary | 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). | intra-operatively |