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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02761083
Recruitment Status : Withdrawn (Comparator was not available in the planned setting)
First Posted : May 4, 2016
Last Update Posted : June 10, 2016
Sponsor:
Collaborator:
B.Braun Surgical SA
Information provided by (Responsible Party):
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)


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

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Study Type : Interventional  (Clinical Trial)
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 2016
Estimated Primary Completion Date : March 2017
Estimated Study Completion Date : September 2017

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




Primary Outcome Measures :
  1. 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).

  2. Incidence of Wound dehiscence [ Time Frame: until 3 months post-operatively ]
    A dehiscence of the skin which needs surgical treatment with re-closure

  3. Incidence of Tissue reaction (inflammation) [ Time Frame: until 3 months after surgery ]
    A tissue reaction (inflammation) due to the suture material

  4. Incidence of Suture removal due to adverse events [ Time Frame: until 3 months post-operatively ]
  5. Incidence of Re-suturing due to dehiscence [ Time Frame: until 3 months post-operatively ]
  6. Cumulated frequency of adverse events [ Time Frame: until 3 months postoperatively ]
    (edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes)

  7. Pain (VAS) [ Time Frame: until 3 months postoperatively ]
  8. Discomfort (VAS) [ Time Frame: until 3 months postoperatively ]
  9. Scar formation (VAS) [ Time Frame: until 3 months postoperatively ]
  10. Patient satisfaction (VAS) [ Time Frame: until 3 months postoperatively ]
  11. Patient satisfaction (EQ-5D-5L) [ Time Frame: until 3 months postoperatively ]
  12. Cosmetic Result (VAS) [ Time Frame: until 3 months postoperatively ]
  13. 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02761083


Locations
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Spain
Hospital Can Misses
Ibiza, Baleares, Spain, 07800
Sponsors and Collaborators
Aesculap AG
B.Braun Surgical SA

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Responsible Party: Aesculap AG
ClinicalTrials.gov Identifier: NCT02761083    
Other Study ID Numbers: AAG-O-H-1506
First Posted: May 4, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: June 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Aesculap AG:
Eye surgery
Suture material
Novosyn Quick
Vicryl Rapid
Additional relevant MeSH terms:
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Entropion
Ectropion
Eyelid Diseases
Eye Diseases