Clinical trial · Interventional
PMCF-study Using Novosyn® Quick Suture Material in Ophthalmic Surgery
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Comparator was not available in the planned setting
Summary
Brief summary (as posted)
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
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Blepharoplasty | — | UNRESOLVED | — |
| Dacryocystorhinostomy | — | UNRESOLVED | — |
| Ectropion | — | UNRESOLVED | — |
| Entropion | — | UNRESOLVED | — |
| Eyelid Tumor Resection | — | UNRESOLVED | — |
| Ptosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Novosyn® Quick | Device | — | UNRESOLVED |
| Vicryl® Rapid | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Novosyn® Quick
- description
- Eye surgery using suture material
- interventionNames
- Device: Novosyn® Quick
- type
- ACTIVE_COMPARATOR
- label
- Vicryl® Rapid
- description
- Eye surgery using suture material
- interventionNames
- Device: Vicryl® Rapid
Primary outcomes (13)
- measure
- Wound infection rate
- timeFrame
- 3 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients undergoing an elective, primary ophthalmic surgery for dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, and blepharoplasty. * Age ≥18 years * Written informed consent Exclusion Criteria: * 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.)
References
Publications (0)
Data not yet available