NCT02761083

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)

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2016

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 4, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

June 10, 2016

Status Verified

June 1, 2016

Enrollment Period

10 months

First QC Date

May 3, 2016

Last Update Submit

June 9, 2016

Conditions

DacryocystorhinostomyEctropionEntropionPtosisEyelid Tumor ResectionBlepharoplasty

Keywords

Eye surgerySuture materialNovosyn QuickVicryl Rapid

Outcome Measures

Primary Outcomes (13)

  • 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).

    3 months

  • Incidence of Wound dehiscence

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

    until 3 months post-operatively

  • Incidence of Tissue reaction (inflammation)

    A tissue reaction (inflammation) due to the suture material

    until 3 months after surgery

  • 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

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

    until 3 months postoperatively

  • 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

    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

Study Arms (2)

Novosyn® Quick

EXPERIMENTAL

Eye surgery using suture material

Device: Novosyn® Quick

Vicryl® Rapid

ACTIVE COMPARATOR

Eye surgery using suture material

Device: Vicryl® Rapid

Interventions

Novosyn® QuickDEVICE

Eye surgery

Novosyn® Quick
Vicryl® RapidDEVICE

Eye surgery

Vicryl® Rapid

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing an elective, primary ophthalmic surgery for dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, and blepharoplasty.
  • Age ≥18 years
  • Written informed consent

You may not qualify if:

  • 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.)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Can Misses

Ibiza Town, Balearic Islands, 07800, Spain

Location

MeSH Terms

Conditions

EctropionEntropionBlepharoptosis

Condition Hierarchy (Ancestors)

Eyelid DiseasesEye Diseases
0

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 3, 2016

First Posted

May 4, 2016

Study Start

May 1, 2016

Primary Completion

March 1, 2017

Study Completion

September 1, 2017

Last Updated

June 10, 2016

Record last verified: 2016-06

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)