Pediatric and Adult: Mucosal Closure in Facial and Oral SurgeryPRIMOQNCT03355001

Prospective, International Monosyn® Quick - Non Interventional Study

An observational study of Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery and Pediatric and Adult: Skin Closure (Dermal Sutures), run by Aesculap AG at 3 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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®… Read more about this study

Who is it for?: Any age
Conditions the study is for: Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery, Pediatric and Adult: Skin Closure (Dermal Sutures), Women: Episiotomy
What is being tested?: Monosyn® Quick
Type of treatment: Pill or oral medicine, Medical device
How many people: 153 participants
Where: 3 sitesGermany
Study dates: 3 Jan 2018to 21 Sep 2019
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

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

Who may be able to join

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)

Who cannot join

None

Trial locations and contacts

3 sites in 1 country.

Germany3 sites

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

Other trials in Germany

About this study

Official title: 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.

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.)
Being tested: Monosyn® Quick

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Monosyn® QuickDevice
- Mucosal sutures in the facial and oral
- Dermal sutures, particularly in pediatrics
- Episiotomy
- Circumcision

Study groups in NCT03355001
Study group	Role	What they receive
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. Receives: 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. Receives: 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. Receives: Device: Monosyn® Quick

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)

Secondary outcomes (7)

Complications
Descriptive Analysis of dehiscence rates of the skin needing surgical treatment with re-closure
Measured: 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
Measured: 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]
Measured: 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)
Measured: 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.
Measured: 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).
Measured: 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).
Measured: intra-operatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Jan 201821 Sep 2019

First posted28 Nov 2017
Study start3 Jan 2018
Primary completion18 Sep 2019
Study completion21 Sep 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Pediatric and Adult: Mucosal Closure in Facial and Oral SurgeryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 153 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03355001
Sponsor's protocol ID: AAG-O-H-1635
Acronym: PRIMOQ
Status last verified: Dec 2021
First submitted: 26 Oct 2017
Last updated: 11 Jan 2022
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

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 at a glance

From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of the Performance of Monosyn® Quick Suture Material in Different Indications Under Daily Clinical Routine.
ClinicalTrials.gov ID: NCT03355001
Acronym / sponsor ID: PRIMOQ / AAG-O-H-1635
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.)
Study type: Observational
Recruitment status: Completed
Enrolment: 153 participants (actual)
Lead sponsor: Aesculap AGIndustry (pharma, biotech, devices)
Collaborators: B.Braun Surgical SA
Study start: 3 Jan 2018 (actual)
Primary completion: 18 Sep 2019 (actual)
Study completion: 21 Sep 2019 (actual)
First posted: 28 Nov 2017 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The Monosyn® Quick non-interventional study (NIS) has been designed to implement an action within the framework of a proactive post-market surveillance system.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Skin Closure	–	Device: Monosyn® QuickMonosyn® 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.
Urology	–	Device: Monosyn® QuickMonosyn® 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.
Gynecology	–	Device: Monosyn® QuickMonosyn® 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.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
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

Key inclusion criteria (2 listed)

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)

Key exclusion criteria (1 listed)

None

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Monosyn® Quick* Mucosal sutures in the facial and oral * Dermal sutures, particularly in pediatrics * Episiotomy * Circumcision	Device	Gynecology, Skin Closure, Urology

Primary outcome

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

7 secondary outcomes

Complications
Time frame: until day of discharge (approximately 1 week)
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)
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)
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)
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)
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)
Handling of the suture material
Time frame: intra-operatively

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
Results publicationBaumann 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.
Results publicationBaumann 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.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Pediatric and Adult: Mucosal Closure in Facial and Oral Surgery and Pediatric and Adult: Skin Closure (Dermal Sutures), run by Aesculap AG at 3 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complication (time frame: at follow-up visit depending on routine clinical practice (approx. 1-3 months postoperatively)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03355001, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.