PMCF-study Using Novosyn® Quick Suture Material in Ophthalmic Surgery

Study Overview
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Brief Summary
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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)

Official Title
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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.

Conditions
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Dacryocystorhinostomy, Ectropion, Entropion, Ptosis, Eyelid Tumor Resection, Blepharoplasty

Intervention / Treatment
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* Device: Novosyn® Quick
* Device: Vicryl® Rapid


Participation Criteria
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Eligibility Criteria
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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.)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Novosyn® Quick<br>Eye surgery using suture material | Device: Novosyn® Quick<br>* Eye surgery<br>|
| Active Comparator: Vicryl® Rapid<br>Eye surgery using suture material | Device: Vicryl® Rapid<br>* Eye surgery<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 3 months | 
| Incidence of Wound dehiscence | A dehiscence of the skin which needs surgical treatment with re-closure | until 3 months post-operatively | 
| Incidence of Tissue reaction (inflammation) | A tissue reaction (inflammation) due to the suture material | until 3 months after surgery | 
| Incidence of Suture removal due to adverse events |  | until 3 months post-operatively | 
| Incidence of Re-suturing due to dehiscence |  | until 3 months post-operatively | 
| Cumulated frequency of adverse events | (edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes) | until 3 months postoperatively | 
| Pain (VAS) |  | until 3 months postoperatively | 
| Discomfort (VAS) |  | until 3 months postoperatively | 
| Scar formation (VAS) |  | until 3 months postoperatively | 
| Patient satisfaction (VAS) |  | until 3 months postoperatively | 
| Patient satisfaction (EQ-5D-5L) |  | until 3 months postoperatively | 
| Cosmetic Result (VAS) |  | 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). | Intraoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Eye surgery, Suture material, Novosyn Quick, Vicryl Rapid