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

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

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-bli

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)


Detailed Summary:
Sponsor: Aesculap AG

Current Primary Outcome:

  • 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).
  • Incidence of Wound dehiscence [ Time Frame: until 3 months post-operatively ]
    A dehiscence of the skin which needs surgical treatment with re-closure
  • Incidence of Tissue reaction (inflammation) [ Time Frame: until 3 months after surgery ]
    A tissue reaction (inflammation) due to the suture material
  • Incidence of Suture removal due to adverse events [ Time Frame: until 3 months post-operatively ]
  • Incidence of Re-suturing due to dehiscence [ Time Frame: 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)
  • Pain (VAS) [ Time Frame: until 3 months postoperatively ]
  • Discomfort (VAS) [ Time Frame: until 3 months postoperatively ]
  • Scar formation (VAS) [ Time Frame: until 3 months postoperatively ]
  • Patient satisfaction (VAS) [ Time Frame: until 3 months postoperatively ]
  • Patient satisfaction (EQ-5D-5L) [ Time Fra

    Original Primary Outcome:

    • 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).
    • Incidence of Wound dehiscence [ Time Frame: until 3 months post-operatively ]
      A dehiscence of the skin which needs surgical treatment with re-closure
    • Incidence of Tissue reaction / inflammation [ Time Frame: until 3 months after surgery ]
    • Incidence of Suture removal due to adverse events [ Time Frame: until 3 months post-operatively ]
    • Incidence of Re-suturing due to dehiscence [ Time Frame: 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)
    • Pain (VAS) [ Time Frame: until 3 months postoperatively ]
    • Discomfort (VAS) [ Time Frame: until 3 months postoperatively ]
    • Scar formation (VAS) [ Time Frame: until 3 months postoperatively ]
    • Patient satisfaction (VAS) [ Time Frame: until 3 months postoperatively ]
    • Patient satisfaction (EQ-5D-5L) [ Time Frame: until 3 months postoperatively ]
    • Cosmetic Result (VAS) [ 

      Current Secondary Outcome:

      Original Secondary Outcome:

      Information By: Aesculap AG

      Dates:
      Date Received: May 3, 2016
      Date Started: May 2016
      Date Completion: September 2017
      Last Updated: June 9, 2016
      Last Verified: June 2016