PMCF-study Using Novosyn® Quick Suture Material in Ophthalmic Surgery (OPHTHALNOQ)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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)
Sex
Ages
Volunteers
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.)
Trial design
Primary purpose
Allocation
Interventional model
Masking
0 participants in 2 patient groups
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal