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

Ptosis Clinical Trial

— OPHTHALNOQ  

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.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02761083
• Other study ID #: AAG-O-H-1506
• Status: Withdrawn
• Phase: Phase 4
• First received: May 3, 2016
• Last updated: June 9, 2016
• Start date: May 2016
• Est. completion date: September 2017

Study information

• Verified date: June 2016
• Source: Aesculap AG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical Trial 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)

Recruitment information / eligibility

• Status: Withdrawn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.)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Blepharoplasty
• Dacryocystorhinostomy
• Ectropion
• Entropion
• Eyelid Tumor Resection
• Ptosis

Intervention

Device:
• Novosyn® Quick
Eye surgery
• Vicryl® Rapid
Eye surgery

Locations

Country	Name	City	State
Spain	Hospital Can Misses	Ibiza	Baleares

Sponsors (2)

Lead Sponsor	Collaborator
Aesculap AG	B.Braun Surgical SA

Country where clinical trial is conducted

Spain, 

Outcome

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