Prospective, International Monosyn® Quick - Non Interventional Study

NCT03355001 | Completed

• 1 other identifier: AAG-O-H-1635
• Study Type: observational
• Target: 153
• Locations: 1 country
• Sites: 3

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.

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.)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Complications

  until day of discharge (approximately 1 week)

• Dehiscence

  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)

  at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)

• Cosmetic outcome

  at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)

• Pain

  at day of discharge (approximately 1 week) and at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)

Study Arms (3)

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

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

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

Interventions

Monosyn® Quick DEVICE

* Mucosal sutures in the facial and oral * Dermal sutures, particularly in pediatrics * Episiotomy * Circumcision

Gynecology; Skin Closure; Urology

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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)

You may not qualify if:

• \- None

Sponsors & Collaborators

• Aesculap AG: lead
• B.Braun Surgical SA: collaborator

Study Sites (3)

Leopoldina-Krankenhaus GmbH

Schweinfurt, Bavaria, 97422, Germany

Location

Benedictus Krankenhaus Tutzing GmbH & Co.

Tutzing, Bavaria, 82327, Germany

Location

Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology

Frankfurt am Main, Hesse, 60590, Germany

Location

Related 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.

  RESULT

• 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.

  RESULT

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2017
• First Posted: November 28, 2017
• Study Start: January 3, 2018
• Primary Completion: September 18, 2019
• Study Completion: September 21, 2019
• Last Updated: January 11, 2022

Record last verified: 2021-12

Locations

DE (3)