Prospective, International Monosyn® Quick - Non Interventional Study (NCT03355001) | Clinical Trial Compass
CompletedNot Applicable
Prospective, International Monosyn® Quick - Non Interventional Study
Germany153 participantsStarted 2018-01-03
Plain-language 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.
Who can participate
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Since this study has already been completed, has the data been published, and what complications were actually recorded when Monosyn Quick was used for the type of closure I need — whether that's skin, mucosal, or episiotomy repair?
2This was a non-interventional observational study rather than a randomized controlled trial — does that mean the evidence it provides about Monosyn Quick's safety is less definitive than a traditional clinical trial, and how should that affect my confidence in this suture material?
3Given that the primary outcome measured in this study was complications, what kinds of complications were they tracking — things like wound dehiscence, infection, or tissue reaction — and are any of those relevant risks for my specific procedure?
4How does Monosyn Quick compare to the suture materials you would normally use for my procedure, and does the evidence from this completed study give you any reason to prefer or avoid it in my case?
5If this suture was studied across a wide range of uses including pediatric urological procedures, facial surgery, and episiotomy, does the data from the specific procedure type most relevant to me show anything worth discussing before we decide on the right approach for my care?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Complication
Timeframe: at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)