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

Aesculap AG (Industry)
Overall Status
CT.gov ID
B.Braun Surgical SA (Industry)

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
  • Device: Novosyn® Quick
  • Device: Vicryl® Rapid
Phase 4

Study Design

Study Type:
Actual Enrollment :
0 participants
Intervention Model:
Parallel Assignment
Double (Participant, Outcomes Assessor)
Primary Purpose:
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

Outcome Measures

Primary Outcome Measures

  1. 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).

  2. Incidence of Wound dehiscence [until 3 months post-operatively]

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

  3. Incidence of Tissue reaction (inflammation) [until 3 months after surgery]

    A tissue reaction (inflammation) due to the suture material

  4. Incidence of Suture removal due to adverse events [until 3 months post-operatively]

  5. Incidence of Re-suturing due to dehiscence [until 3 months post-operatively]

  6. Cumulated frequency of adverse events [until 3 months postoperatively]

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

  7. Pain (VAS) [until 3 months postoperatively]

  8. Discomfort (VAS) [until 3 months postoperatively]

  9. Scar formation (VAS) [until 3 months postoperatively]

  10. Patient satisfaction (VAS) [until 3 months postoperatively]

  11. Patient satisfaction (EQ-5D-5L) [until 3 months postoperatively]

  12. Cosmetic Result (VAS) [until 3 months postoperatively]

  13. 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


Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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.)

Contacts and Locations


Site City State Country Postal Code
1 Hospital Can Misses Ibiza Baleares Spain 07800

Sponsors and Collaborators

  • Aesculap AG
  • B.Braun Surgical SA


None specified.

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Aesculap AG
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • AAG-O-H-1506
First Posted:
May 4, 2016
Last Update Posted:
Jun 10, 2016
Last Verified:
Jun 1, 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Keywords provided by Aesculap AG
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 10, 2016