DacryocystorhinostomyPhase 4OPHTHALNOQNCT02761083
PMCF-study Using Novosyn® Quick Suture Material in Ophthalmic Surgery
A Phase 4 study testing Novosyn® Quick and Vicryl® Rapid in people with Dacryocystorhinostomy and Ectropion, run by Aesculap AG at 1 site in Spain.
Trial summary
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with standard suture material used in Ophthalmic surgery. In order to show that, various safety and efficacy parameters have been selected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dacryocystorhinostomy, Ectropion, Entropion
- What is being tested?
- Novosyn® Quick and Vicryl® Rapid
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSpain
- Study dates
- May 2016to Sep 2017
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing an elective, primary ophthalmic surgery for dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, and blepharoplasty.
- Age ≥18 years
- Written informed consent
Who cannot join
- Emergency surgery
- Previous ophthalmic surgery on the same eye
- Known allergy or inflammation reaction to suture material similar to Vicryl® Rapide or Novosyn® Quíck in previous surgery.
- Cicatrisation base alterations
- Concomitant medication, that might affect wound healing (e.g. immunosuppression therapy, anti-diabetic drugs, etc.)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post-Marketing Clinical Follow-up (PMCF) Study in Ophthalmic Surgery to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material. A Multicenter Randomized, Active-controlled, Double-blinded, Prospective, Observational Study.
The aim of this study is to show that the performance of Novosyn® Quick suture material is comparable with standard suture material used in Ophthalmic surgery. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be compared in 2 treatment groups. Active control group will receive Vicryl® Rapide and the treatment group Novosyn® Quick for ophthalmic surgery. It was decided to design this study as a randomized trial, because limited clinical evidence is available in the literature for the active control group (Vicryl® Rapide) which can be used for comparison. Eye operation will be randomly allocated on the left and right side (1:1) to both treatment groups.
Patients undergoing elective, primary ophthalmic surgery (dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, blepharoplasty)
- Conditions
- Dacryocystorhinostomy, Ectropion, Entropion, Ptosis, Eyelid Tumor Resection, Blepharoplasty
- Being tested
- Novosyn® Quick, Vicryl® Rapid
- Keywords
- Eye surgery, Suture material, Novosyn Quick, Vicryl Rapid
- Medical subject headings
- Ectropion, Entropion, Blepharoptosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Novosyn® QuickDevice
Eye surgery
Vicryl® RapidDevice
Eye surgery
| Study group | Role | What they receive |
|---|---|---|
| Novosyn® Quick | Experimental | Eye surgery using suture material Receives: Device: Novosyn® Quick |
| Vicryl® Rapid | Active comparator | Eye surgery using suture material Receives: Device: Vicryl® Rapid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound infection rate
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: until 3 months post-operatively
Incidence of Tissue reaction (inflammation)
A tissue reaction (inflammation) due to the suture material
Measured: until 3 months after surgery
Incidence of Suture removal due to adverse events
Measured: until 3 months post-operatively
Incidence of Re-suturing due to dehiscence
Measured: until 3 months post-operatively
Cumulated frequency of adverse events
(edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes)
Measured: until 3 months postoperatively
Pain (VAS)
Measured: until 3 months postoperatively
Discomfort (VAS)
Measured: until 3 months postoperatively
Scar formation (VAS)
Measured: until 3 months postoperatively
Patient satisfaction (VAS)
Measured: until 3 months postoperatively
Patient satisfaction (EQ-5D-5L)
Measured: until 3 months postoperatively
Cosmetic Result (VAS)
Measured: until 3 months postoperatively
Handling of the suture
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: Intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2016 (estimated)
- Study startMay 2016
- Primary completionMar 2017 (estimated)
- Study completionSep 2017 (estimated)
Why it stopped: Comparator was not available in the planned setting
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DacryocystorhinostomyStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 0 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
- NCT02761083
- Sponsor's protocol ID
- AAG-O-H-1506
- Acronym
- OPHTHALNOQ
- Status last verified
- Jun 2016
- First submitted
- 3 May 2016
- Last updated
- 10 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Clinical Follow-up (PMCF) Study in Ophthalmic Surgery to Evaluate the Safety and Efficacy of Novosyn® Quick Suture Material. A Multicenter Randomized, Active-controlled, Double-blinded, Prospective, Observational Study.
- ClinicalTrials.gov ID
- NCT02761083
- Acronym / sponsor ID
- OPHTHALNOQ / AAG-O-H-1506
- Conditions
- Dacryocystorhinostomy, Ectropion, Entropion, Ptosis, Eyelid Tumor Resection, Blepharoplasty
- Keywords
- Eye surgery, Suture material, Novosyn Quick, Vicryl Rapid
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Comparator was not available in the planned setting
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aesculap AGIndustry (pharma, biotech, devices)
- Collaborators
- B.Braun Surgical SA
- Study start
- May 2016
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Sep 2017 (estimated)
- First posted
- 4 May 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 standard suture material used in Ophthalmic surgery. In order to show that, various safety and efficacy parameters have been selected. The outcome regarding these parameters will be compared in 2 treatment groups. Active control group will receive Vicryl® Rapide and the treatment group Novosyn® Quick for ophthalmic surgery. It was decided to design this study as a randomized trial, because limited clinical evidence is available in the literature for the active control group (Vicryl® Rapide) which can be used for comparison. Eye operation will be randomly allocated on the left and right side (1:1) to both treatment groups.
Patients undergoing elective, primary ophthalmic surgery (dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, blepharoplasty)
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Novosyn® Quick | Experimental | Device: Novosyn® QuickEye surgery using suture material |
| Vicryl® Rapid | Active comparator | Device: Vicryl® RapidEye surgery using suture material |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients undergoing an elective, primary ophthalmic surgery for dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, and blepharoplasty.
- Age ≥18 years
- Written informed consent
Key exclusion criteria (5 listed)
- Emergency surgery
- Previous ophthalmic surgery on the same eye
- Known allergy or inflammation reaction to suture material similar to Vicryl® Rapide or Novosyn® Quíck in previous surgery.
- Cicatrisation base alterations
- Concomitant medication, that might affect wound healing (e.g. immunosuppression therapy, anti-diabetic drugs, etc.)
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® QuickEye surgery | Device | Novosyn® Quick |
| Vicryl® RapidEye surgery | Device | Vicryl® Rapid |
Primary outcome
Wound infection rate
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: until 3 months post-operatively
A dehiscence of the skin which needs surgical treatment with re-closure
Incidence of Tissue reaction (inflammation)
Time frame: until 3 months after surgery
A tissue reaction (inflammation) due to the suture material
Incidence of Suture removal due to adverse events
Time frame: until 3 months post-operatively
Incidence of Re-suturing due to dehiscence
Time frame: until 3 months post-operatively
Cumulated frequency of adverse events
Time frame: until 3 months postoperatively
(edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes)
Pain (VAS)
Time frame: until 3 months postoperatively
Discomfort (VAS)
Time frame: until 3 months postoperatively
Scar formation (VAS)
Time frame: until 3 months postoperatively
Patient satisfaction (VAS)
Time frame: until 3 months postoperatively
Patient satisfaction (EQ-5D-5L)
Time frame: until 3 months postoperatively
Cosmetic Result (VAS)
Time frame: until 3 months postoperatively
Handling of the suture
Time frame: Intraoperative
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 was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2016.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Novosyn® Quick and Vicryl® Rapid in people with Dacryocystorhinostomy and Ectropion, run by Aesculap AG at 1 site in Spain.
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: withdrawn, as of the sponsor's last update on 10 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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 rate (time frame: 3 months). The study lists 13 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jun 2016.