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

June 9, 2016 updated by: Aesculap AG

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.

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 Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Baleares
      • Ibiza, Baleares, Spain, 07800
        • Hospital Can Misses

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aesculap AG

Collaborators

B.Braun Surgical SA

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2016

Primary Completion (Anticipated)

March 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

May 3, 2016

First Submitted That Met QC Criteria

May 3, 2016

First Posted (Estimate)

May 4, 2016

Study Record Updates

Last Update Posted (Estimate)

June 10, 2016

Last Update Submitted That Met QC Criteria

June 9, 2016

Last Verified

June 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AAG-O-H-1506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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