Clinical trial NCT02761083: PMCF-study Using Novosyn® Quick Suture Material in Ophthalmic Surgery
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
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Dacryocystorhinostomy
Ectropion
Entropion
Ptosis
Eyelid Tumor Resection
Blepharoplasty
Keywords: Eye surgery
Suture material
Novosyn Quick
Vicryl Rapid
Lead sponsor: Aesculap AG
Sponsor class: INDUSTRY
Collaborators: name: B.Braun Surgical SA
First posted: 2016-05-04
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)


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.)

Primary outcomes:
measure: Wound infection rate
timeFrame: 3 months
measure: Incidence of Wound dehiscence
timeFrame: until 3 months post-operatively
measure: Incidence of Tissue reaction (inflammation)
timeFrame: until 3 months after surgery
measure: Incidence of Suture removal due to adverse events
timeFrame: until 3 months post-operatively
measure: Incidence of Re-suturing due to dehiscence
timeFrame: until 3 months post-operatively
measure: Cumulated frequency of adverse events
timeFrame: until 3 months postoperatively
measure: Pain (VAS)
timeFrame: until 3 months postoperatively
measure: Discomfort (VAS)
timeFrame: until 3 months postoperatively
measure: Scar formation (VAS)
timeFrame: until 3 months postoperatively
measure: Patient satisfaction (VAS)
timeFrame: until 3 months postoperatively
measure: Patient satisfaction (EQ-5D-5L)
timeFrame: until 3 months postoperatively
measure: Cosmetic Result (VAS)
timeFrame: until 3 months postoperatively
measure: Handling of the suture
timeFrame: Intraoperative
Secondary outcomes:
Other outcomes:
Locations:
city: Ibiza
country: Spain
facility: Hospital Can Misses
state: Baleares
Study officials:
References: