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

NCT02761083 — Phase 4, Withdrawn, Aesculap AG

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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.

Registry	NCT02761083, acronym OPHTHALNOQ
Status	Withdrawn - Comparator was not available in the planned setting
Phase	Phase 4
Study type	Interventional; randomized, parallel, masking: double, treatment
Sponsor	Aesculap AG (Industry); collaborators: B.Braun Surgical SA
Conditions	Dacryocystorhinostomy, Ectropion, Entropion, Ptosis, Eyelid Tumor Resection, Blepharoplasty
Interventions	Novosyn® Quick, Vicryl® Rapid (Device)
Dates	start 2016-05-01, primary completion 2017-03-01 (estimated), completion 2017-09-01 (estimated), first posted 2016-05-04, last updated 2016-06-10
Locations	1 site in Spain

-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)

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+Arms and interventions

Arm	Type	Interventions	Description
Novosyn® Quick	Experimental	Device: Novosyn® Quick	Eye surgery using suture material
Vicryl® Rapid	Active comparator	Device: Vicryl® Rapid	Eye surgery using suture material

Novosyn® Quick (Device): Eye surgery
Vicryl® Rapid (Device): Eye surgery

+Outcome measures

Primary outcomes

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).
Incidence of Wound dehiscence [until 3 months post-operatively]: A dehiscence of the skin which needs surgical treatment with re-closure
Incidence of Tissue reaction (inflammation) [until 3 months after surgery]: A tissue reaction (inflammation) due to the suture material
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 [until 3 months postoperatively]: (edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes)
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 [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

Sex: All, ages: 18 Years to any

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.)

+Locations (1)

Facility	City	Country	Status
Hospital Can Misses	Ibiza Town, Balearic Islands	Spain