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

Phase 4

Withdrawn

• Conditions: Entropion; Dacryocystorhinostomy; Ectropion; Ptosis; Blepharoplasty; Eyelid Tumor Resection
• Interventions: Device: Novosyn® Quick; Device: Vicryl® Rapid

• Registration Number: NCT02761083
• Lead Sponsor: Aesculap AG

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)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-03
• Study First Submitted QC: 2016-05-03
• Study First Posted: 2016-05-04
• Status Verified: 2016-06
• Last Update Submitted: 2016-06-09
• Last Update Posted: 2016-06-10
• Primary Completion: 2017-03
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Novosyn® Quick	Novosyn® Quick	Eye surgery using suture material
Vicryl® Rapid	Vicryl® Rapid	Eye surgery using suture material

Primary Outcome Measures

Name	Time	Method
Pain (VAS)	until 3 months postoperatively
Incidence of Wound dehiscence	until 3 months post-operatively	A dehiscence of the skin which needs surgical treatment with re-closure
Incidence of Re-suturing due to dehiscence	until 3 months post-operatively
Scar formation (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 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
Cumulated frequency of adverse events	until 3 months postoperatively	(edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes)
Discomfort (VAS)	until 3 months postoperatively
Patient satisfaction (VAS)	until 3 months postoperatively
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).

Trial Locations

Locations (1)

Hospital Can Misses; 🇪🇸 Ibiza, Baleares, Spain