Ptosis Clinical Trial
— OPHTHALNOQOfficial 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.
Verified date | June 2016 |
Source | Aesculap AG |
Contact | n/a |
Is FDA regulated | No |
Health authority | Spain: Ethics Committee |
Study type | Interventional |
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)
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | September 2017 |
Est. primary completion date | March 2017 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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.) |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Can Misses | Ibiza | Baleares |
Lead Sponsor | Collaborator |
---|---|
Aesculap AG | B.Braun Surgical SA |
Spain,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Wound infection rate | Wound infection (Surgical site infection, SSI) is defined according to the definition of the US Centres for Disease Control and Prevention (CDC). | 3 months | Yes |
Primary | Incidence of Wound dehiscence | A dehiscence of the skin which needs surgical treatment with re-closure | until 3 months post-operatively | Yes |
Primary | Incidence of Tissue reaction (inflammation) | A tissue reaction (inflammation) due to the suture material | until 3 months after surgery | Yes |
Primary | Incidence of Suture removal due to adverse events | until 3 months post-operatively | Yes | |
Primary | Incidence of Re-suturing due to dehiscence | until 3 months post-operatively | Yes | |
Primary | Cumulated frequency of adverse events | (edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes) | until 3 months postoperatively | Yes |
Primary | Pain (VAS) | until 3 months postoperatively | No | |
Primary | Discomfort (VAS) | until 3 months postoperatively | No | |
Primary | Scar formation (VAS) | until 3 months postoperatively | No | |
Primary | Patient satisfaction (VAS) | until 3 months postoperatively | No | |
Primary | Patient satisfaction (EQ-5D-5L) | until 3 months postoperatively | No | |
Primary | Cosmetic Result (VAS) | until 3 months postoperatively | No | |
Primary | Handling of the suture | 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). | Intraoperative | No |
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