WithdrawnPhase 4

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

Stopped: Comparator was not available in the planned setting

Spain0Started 2016-05

Plain-language 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)

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Wound infection rate

Timeframe: 3 months

Incidence of Wound dehiscence

Timeframe: until 3 months post-operatively

Incidence of Tissue reaction (inflammation)

Timeframe: until 3 months after surgery

Incidence of Suture removal due to adverse events

Timeframe: until 3 months post-operatively

Incidence of Re-suturing due to dehiscence

Timeframe: until 3 months post-operatively

Cumulated frequency of adverse events

Timeframe: until 3 months postoperatively

Pain (VAS)

Timeframe: until 3 months postoperatively

Discomfort (VAS)

Trial details

NCT IDNCT02761083

SponsorAesculap AG

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-03

View on ClinicalTrials.gov More Dacryocystorhinostomy trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Wound infection rate

Timeframe: 3 months

Incidence of Wound dehiscence

Timeframe: until 3 months post-operatively

Incidence of Tissue reaction (inflammation)

Timeframe: until 3 months after surgery

Incidence of Suture removal due to adverse events

Timeframe: until 3 months post-operatively

Incidence of Re-suturing due to dehiscence

Timeframe: until 3 months post-operatively

Cumulated frequency of adverse events

Timeframe: until 3 months postoperatively

Pain (VAS)

Timeframe: until 3 months postoperatively

Discomfort (VAS)