Stopped: Comparator was not available in the planned setting
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)
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Wound infection rate
Timeframe: 3 months
Incidence of Wound dehiscence
Timeframe: until 3 months post-operatively
Incidence of Tissue reaction (inflammation)
Timeframe: until 3 months after surgery
Incidence of Suture removal due to adverse events
Timeframe: until 3 months post-operatively
Incidence of Re-suturing due to dehiscence
Timeframe: until 3 months post-operatively
Cumulated frequency of adverse events
Timeframe: until 3 months postoperatively
Pain (VAS)
Timeframe: until 3 months postoperatively
Discomfort (VAS)
Timeframe: until 3 months postoperatively
Scar formation (VAS)
Timeframe: until 3 months postoperatively
Patient satisfaction (VAS)
Timeframe: until 3 months postoperatively
Patient satisfaction (EQ-5D-5L)
Timeframe: until 3 months postoperatively
Cosmetic Result (VAS)
Timeframe: until 3 months postoperatively
Handling of the suture
Timeframe: Intraoperative