Prospective, International Monosyn® Quick - Non Interventional Study (PRIMOQ)

Assessment of the Performance of Monosyn® Quick Suture Material in Different Indications Under Daily Clinical Routine.

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 Overview

• Status: Completed
• Conditions: Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery; Pediatric and Adult: Skin Closure (Dermal Sutures); Women: Episiotomy; Pediatric: Urological Interventions (Circumcision, Phimosis Etc.)
• Intervention / Treatment: Device: Monosyn® Quick

• Study Type: Observational
• Enrollment (Actual): 153

Contacts and Locations

Study Locations

• Germany
  • Bayern
    • Schweinfurt, Bayern, Germany, 97422
      • Leopoldina-Krankenhaus GmbH
    • Tutzing, Bayern, Germany, 82327
      • Benedictus Krankenhaus Tutzing GmbH & Co.
  • Hessen
    • Frankfurt am Main, Hessen, Germany, 60590
      • Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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 as a circumcision or phimosis or hypospadias

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Skin Closure; 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.	Device: Monosyn® Quick; Mucosal sutures in the facial and oral; Dermal sutures, particularly in pediatrics; Episiotomy; Circumcision
Urology; 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.	Device: Monosyn® Quick; Mucosal sutures in the facial and oral; Dermal sutures, particularly in pediatrics; Episiotomy; Circumcision
Gynecology; 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.	Device: Monosyn® Quick; Mucosal sutures in the facial and oral; Dermal sutures, particularly in pediatrics; Episiotomy; Circumcision

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Descriptive Analysis of dehiscence rates of the skin needing surgical treatment with re-closure	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	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]	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)	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.	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).	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).	intra-operatively

Collaborators and Investigators

• Sponsor: Aesculap AG
• Collaborators: B.Braun Surgical SA

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 3, 2018
• Primary Completion (Actual): September 18, 2019
• Study Completion (Actual): September 21, 2019

Study Registration Dates

• First Submitted: October 26, 2017
• First Submitted That Met QC Criteria: November 21, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): January 11, 2022
• Last Update Submitted That Met QC Criteria: December 21, 2021
• Last Verified: December 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Penile Diseases; Phimosis
• Other Study ID Numbers: AAG-O-H-1635

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No