Skin ClosureSKINNOQNCT02680886
PMCF-study Using Novosyn® Quick Suture Material for Skin Closure
An observational study of Skin Closure, run by Aesculap AG at 2 sites in 2 countries.
Trial summary
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for skin closure. In order to show that, various safety and efficacy parameters have been selected. Read more about this study
- Who is it for?
- Ages 1 year and older
- Conditions the study is for
- Skin Closure
- What is being tested?
- Novosyn® Quick
- Type of treatment
- Medical device
- How many people
- 100 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Mar 2016to Jan 2018
- 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 1 year and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: children and adults
Who may be able to join
- Pediatric and adult patients undergoing skin closure
- Small linear minimally contaminated incision / lacerations on the trunk or extremities
- Written informed consent
Who cannot join
- Emergency surgery
- Facial lacerations or incisions
- Visible dirt in the wounds
- Nonlinear shape
- Patients taking medical consumption that might affect wound healing
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Germany1 site
Klinikum der Johann-Wolfgang-Goethe Universität, Department for Pediatric Surgery and Pediatric Urology
Frankfurt am Main, 60590
About this study
Official title: Post-Marketing Clinical Follow-up (PMCF) Study for Skin Closure to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material. A Multicenter, International, Prospective, Observational Study
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for skin closure. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature.
- Conditions
- Skin Closure
- Being tested
- Novosyn® Quick
- Keywords
- Rapid Absorbable Suture Material, Children / Adults, Novosyn Quick
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novosyn® QuickDevice
Skin closure
| Study group | Role | What they receive |
|---|---|---|
| Novosyn® Quick | Skin closure using rapid absorbable suture material Receives: Device: Novosyn® Quick |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound infection
Wound infection (Surgical site infection, SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC).
Measured: 3 months
Incidence of wound dehiscence
A dehiscence of the skin which needs surgical treatment with re-closure
Measured: 3 months postoperatively
Incidence of Tissue reaction / Inflammation
Measured: 3 months postoperatively
Incidence of Suture removal
Suture removal due to insufficient absorption
Measured: 3 months postoperatively
Incidence of Re-suturing
Re-Suturing due to dehiscence
Measured: 3 months post-operatively
Cosmetic result
Cosmetic result after surgery using the Patient and Observer Scar Assessment Scale (POSAS). Cosmetic result and the scar will be evaluated by the patient and the physician. Patient will rate the cosmetic outcome using the patient component of the Patient and Observer Scar Assessment Scale (POSAS). The physician will use the Observer component of the POSAS to assess the cosmetic outcome.
Documentation of the scar will be performed 3 months postoperatively using photographs.
Overall patient and observer satisfaction with the scar after 3 months postoperatively (POSAS).
Measured: 3 months post-operatively
Assessment of the handling of the suture material
Assessment of the handling of the suture material intra-operatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag etc.) with 5 evaluations levels (excellent, very good, good, satisfied, poor).
Measured: intraoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2016 (estimated)
- Study startMar 2016
- Primary completionOct 2017
- Study completionJan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Skin ClosureStudies 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
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aesculap AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02680886
- Sponsor's protocol ID
- AAG-O-H-1505
- Acronym
- SKINNOQ
- Status last verified
- Jan 2018
- First submitted
- 5 Feb 2016
- Last updated
- 4 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gfroerer S, Baumann P, Schwalbach AK, Smirnoff A. Prospective international multicenter observational study of Novosyn(R) Quick for skin closures in adults and children (SKINNOQ). BMC Surg. 2019 May 2;19(1):47. doi: 10.1186/s12893-019-0506-8.
PubMed 31046730
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Clinical Follow-up (PMCF) Study for Skin Closure to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material. A Multicenter, International, Prospective, Observational Study
- ClinicalTrials.gov ID
- NCT02680886
- Acronym / sponsor ID
- SKINNOQ / AAG-O-H-1505
- Conditions
- Skin Closure
- Keywords
- Rapid Absorbable Suture Material, Children / Adults, Novosyn Quick
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- Mar 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jan 2018 (actual)
- First posted
- 12 Feb 2016 (estimated)
- 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 aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with other suture material used for skin closure. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be evaluated by a quantitative summary of the available clinical data from the literature.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Novosyn® Quick | – | Device: Novosyn® QuickSkin closure using rapid absorbable suture material |
Who may qualify
- Ages
- 1 year and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- children and adults
Key inclusion criteria (3 listed)
- Pediatric and adult patients undergoing skin closure
- Small linear minimally contaminated incision / lacerations on the trunk or extremities
- Written informed consent
Key exclusion criteria (5 listed)
- Emergency surgery
- Facial lacerations or incisions
- Visible dirt in the wounds
- Nonlinear shape
- Patients taking medical consumption that might affect wound healing
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 |
|---|---|---|
| Novosyn® QuickSkin closure | Device | Novosyn® Quick |
Primary outcome
Wound infection
Time frame: 3 months
Wound infection (Surgical site infection, SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC).
Incidence of wound dehiscence
Time frame: 3 months postoperatively
A dehiscence of the skin which needs surgical treatment with re-closure
Incidence of Tissue reaction / Inflammation
Time frame: 3 months postoperatively
Incidence of Suture removal
Time frame: 3 months postoperatively
Suture removal due to insufficient absorption
Incidence of Re-suturing
Time frame: 3 months post-operatively
Re-Suturing due to dehiscence
Cosmetic result
Time frame: 3 months post-operatively
Cosmetic result after surgery using the Patient and Observer Scar Assessment Scale (POSAS). Cosmetic result and the scar will be evaluated by the patient and the physician. Patient will rate the cosmetic outcome using the patient component of the Patient and Observer Scar Assessment Scale (POSAS). The physician will use the Observer component of the POSAS to assess the cosmetic outcome. Documentation of the scar will be performed 3 months postoperatively using photographs. Overall patient and observer satisfaction with the scar after 3 months postoperatively (POSAS).
Assessment of the handling of the suture material
Time frame: intraoperatively
Assessment of the handling of the suture material intra-operatively using a questionnaire including different dimensions (knot security, tensile strength, knot run down, tissue drag etc.) with 5 evaluations levels (excellent, very good, good, satisfied, poor).
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 4 May 2018.
- Derived from this study: PubMed 31046730Gfroerer S, Baumann P, Schwalbach AK, Smirnoff A. Prospective international multicenter observational study of Novosyn(R) Quick for skin closures in adults and children (SKINNOQ). BMC Surg. 2019 May 2;19(1):47. doi: 10.1186/s12893-019-0506-8.
- Individual participant dataSharing planned: No
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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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skin Closure, run by Aesculap AG at 2 sites in 2 countries.
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 3 inclusion and 5 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 4 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, 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?
Wound infection (time frame: 3 months). The study lists 7 primary outcomes in all. 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 NCT02680886, which also lists 1 linked publication.
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 4 May 2018.