Blepharoplasty, Dacryocystorhinostomy, Ectropion, Entropion, Eyelid Tumor Resection, Ptosis
Conditions
Keywords
Eye surgery, Suture material, Novosyn Quick, Vicryl Rapid
Brief summary
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)
Interventions
DEVICENovosyn® Quick
Eye surgery
DEVICEVicryl® Rapid
Eye surgery
Sponsors
B.Braun Surgical SA
Aesculap AG
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Wound infection rate | 3 months | Wound infection (Surgical site infection, SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC). |
| Incidence of Wound dehiscence | until 3 months post-operatively | A dehiscence of the skin which needs surgical treatment with re-closure |
| Incidence of Tissue reaction (inflammation) | until 3 months after surgery | A tissue reaction (inflammation) due to the suture material |
| 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 | until 3 months postoperatively | (edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes) |
| Handling of the suture | Intraoperative | 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). |
Countries
Spain
Outcome results
None listed