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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03355001
Other study ID # AAG-O-H-1635
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 3, 2018
Est. completion date September 21, 2019

Study information

Verified date December 2021
Source Aesculap AG
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

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

Study Design


Related Conditions & MeSH terms

  • Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery
  • Pediatric and Adult: Skin Closure (Dermal Sutures)
  • Pediatric: Urological Interventions (Circumcision, Phimosis Etc.)
  • Phimosis
  • Women: Episiotomy

Intervention

Device:
Monosyn® Quick
Mucosal sutures in the facial and oral Dermal sutures, particularly in pediatrics Episiotomy Circumcision

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
Aesculap AG B.Braun Surgical SA

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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.

Outcome

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