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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03355001
Recruitment Status : Completed
First Posted : November 28, 2017
Last Update Posted : April 22, 2020
Sponsor:
Collaborator:
B.Braun Surgical SA
Information provided by (Responsible Party):
Aesculap AG

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.


Condition or disease Intervention/treatment
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.) Device: Monosyn® Quick

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Study Type : Observational
Actual Enrollment : 153 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Assessment of the Performance of Monosyn® Quick Suture Material in Different Indications Under Daily Clinical Routine.
Actual Study Start Date : January 3, 2018
Actual Primary Completion Date : September 18, 2019
Actual Study Completion Date : September 21, 2019

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




Primary Outcome Measures :
  1. Complication [ Time Frame: 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 Outcome Measures :
  1. Complications [ Time Frame: until day of discharge (approximately 1 week) ]
    Descriptive Analysis of dehiscence rates of the skin needing surgical treatment with re-closure

  2. Dehiscence [ Time Frame: 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

  3. Patient and Observer Scar Assessment Scale (POSAS) [ Time Frame: 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]

  4. Cosmetic outcome [ Time Frame: 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)

  5. Pain [ Time Frame: 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.

  6. Satisfaction of the patient [ Time Frame: 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).

  7. Handling of the suture material [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03355001


Locations
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Germany
Leopoldina-Krankenhaus GmbH
Schweinfurt, Bayern, Germany, 97422
Benedictus Krankenhaus Tutzing GmbH & Co.
Tutzing, Bayern, Germany, 82327
Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology
Frankfurt am Main, Hessen, Germany, 60590
Sponsors and Collaborators
Aesculap AG
B.Braun Surgical SA
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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT03355001    
Other Study ID Numbers: AAG-O-H-1635
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: April 22, 2020
Last Verified: April 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Phimosis
Penile Diseases
Genital Diseases, Male