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

Sponsor

Aesculap AG (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT02761083

Collaborator

B.Braun Surgical SA (Industry)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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)

Condition or Disease	Intervention/Treatment	Phase
Dacryocystorhinostomy Ectropion Entropion Ptosis Eyelid Tumor Resection Blepharoplasty	Device: Novosyn® Quick Device: Vicryl® Rapid	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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.

Study Start Date :

May 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2017

Anticipated Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Novosyn® Quick Eye surgery using suture material	Device: Novosyn® Quick Eye surgery
Active Comparator: Vicryl® Rapid Eye surgery using suture material	Device: Vicryl® Rapid Eye surgery

Arm

Intervention/Treatment

Experimental: Novosyn® Quick

Eye surgery using suture material

Device: Novosyn® Quick

Eye surgery

Active Comparator: Vicryl® Rapid

Eye surgery using suture material

Device: Vicryl® Rapid

Eye surgery

Outcome Measures

Primary Outcome Measures

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)
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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.)