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

Aesculap AG

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Conditions

Dacryocystorhinostomy Ectropion Entropion Ptosis Eyelid Tumor Resection

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.)

Outcomes

Primary Outcomes

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).

Time frame: 3 months

Incidence of Wound dehiscence

A dehiscence of the skin which needs surgical treatment with re-closure

Time frame: until 3 months post-operatively

Incidence of Tissue reaction (inflammation)

A tissue reaction (inflammation) due to the suture material

Time frame: until 3 months after surgery

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

(edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes)