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

Primary Purpose

Dacryocystorhinostomy, Ectropion, Entropion

Status
Withdrawn
Phase
Phase 4
Locations
Spain
Study Type
Interventional
Intervention
Novosyn® Quick
Vicryl® Rapid
Sponsored by
Aesculap AG
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dacryocystorhinostomy focused on measuring Eye surgery, Suture material, Novosyn Quick, Vicryl Rapid

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.)

Sites / Locations

  • Hospital Can Misses

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Novosyn® Quick

Vicryl® Rapid

Arm Description

Eye surgery using suture material

Eye surgery using suture material

Outcomes

Primary Outcome Measures

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).
Incidence of Wound dehiscence
A dehiscence of the skin which needs surgical treatment with re-closure
Incidence of Tissue reaction (inflammation)
A tissue reaction (inflammation) due to the suture material
Incidence of Suture removal due to adverse events
Incidence of Re-suturing due to dehiscence
Cumulated frequency of adverse events
(edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes)
Pain (VAS)
Discomfort (VAS)
Scar formation (VAS)
Patient satisfaction (VAS)
Patient satisfaction (EQ-5D-5L)
Cosmetic Result (VAS)
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).

Secondary Outcome Measures

Full Information

First Posted
May 3, 2016
Last Updated
June 9, 2016
Sponsor
Aesculap AG
Collaborators
B.Braun Surgical SA
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1. Study Identification

Unique Protocol Identification Number
NCT02761083
Brief Title
PMCF-study Using Novosyn® Quick Suture Material in Ophthalmic Surgery
Acronym
OPHTHALNOQ
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 Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Comparator was not available in the planned setting
Study Start Date
May 2016 (undefined)
Primary Completion Date
March 2017 (Anticipated)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Aesculap AG
Collaborators
B.Braun Surgical SA

4. Oversight

Data Monitoring Committee
No

5. 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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dacryocystorhinostomy, Ectropion, Entropion, Ptosis, Eyelid Tumor Resection, Blepharoplasty
Keywords
Eye surgery, Suture material, Novosyn Quick, Vicryl Rapid

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Novosyn® Quick
Arm Type
Experimental
Arm Description
Eye surgery using suture material
Arm Title
Vicryl® Rapid
Arm Type
Active Comparator
Arm Description
Eye surgery using suture material
Intervention Type
Device
Intervention Name(s)
Novosyn® Quick
Intervention Description
Eye surgery
Intervention Type
Device
Intervention Name(s)
Vicryl® Rapid
Intervention Description
Eye surgery
Primary Outcome Measure Information:
Title
Wound infection rate
Description
Wound infection (Surgical site infection, SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC).
Time Frame
3 months
Title
Incidence of Wound dehiscence
Description
A dehiscence of the skin which needs surgical treatment with re-closure
Time Frame
until 3 months post-operatively
Title
Incidence of Tissue reaction (inflammation)
Description
A tissue reaction (inflammation) due to the suture material
Time Frame
until 3 months after surgery
Title
Incidence of Suture removal due to adverse events
Time Frame
until 3 months post-operatively
Title
Incidence of Re-suturing due to dehiscence
Time Frame
until 3 months post-operatively
Title
Cumulated frequency of adverse events
Description
(edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes)
Time Frame
until 3 months postoperatively
Title
Pain (VAS)
Time Frame
until 3 months postoperatively
Title
Discomfort (VAS)
Time Frame
until 3 months postoperatively
Title
Scar formation (VAS)
Time Frame
until 3 months postoperatively
Title
Patient satisfaction (VAS)
Time Frame
until 3 months postoperatively
Title
Patient satisfaction (EQ-5D-5L)
Time Frame
until 3 months postoperatively
Title
Cosmetic Result (VAS)
Time Frame
until 3 months postoperatively
Title
Handling of the suture
Description
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).
Time Frame
Intraoperative

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.)
Facility Information:
Facility Name
Hospital Can Misses
City
Ibiza
State/Province
Baleares
ZIP/Postal Code
07800
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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