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Completed

NCT Number: NCT03355001

Prospective, International Monosyn® Quick - Non Interventional Study

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Observational

Primary location

Leopoldina-Krankenhaus GmbH, Schweinfurt, Bavaria, Germany

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Monosyn® Quick

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

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

Aesculap AG

Industry

Collaborators

  • B.Braun Surgical SA

Registry information

Official study title

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

Acronym: PRIMOQ

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 28, 2017
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.