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.
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- Aesculap AG
- 试验地点
- 2
- 主要终点
- Pain (VAS)
研究概览
简要总结
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)
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing an elective, primary ophthalmic surgery for dacryocystorhinostomy, ectropion, entropion, ptosis, eyelid tumor resection, and blepharoplasty.
- •Age ≥18 years
- •Written informed consent
排除标准
- •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.)
结局指标
主要结局
Pain (VAS)
时间窗: until 3 months postoperatively
Incidence of Wound dehiscence
时间窗: until 3 months post-operatively
A dehiscence of the skin which needs surgical treatment with re-closure
Incidence of Re-suturing due to dehiscence
时间窗: until 3 months post-operatively
Scar formation (VAS)
时间窗: until 3 months postoperatively
Patient satisfaction (EQ-5D-5L)
时间窗: until 3 months postoperatively
Cosmetic Result (VAS)
时间窗: until 3 months postoperatively
Wound infection rate
时间窗: 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 Tissue reaction (inflammation)
时间窗: until 3 months after surgery
A tissue reaction (inflammation) due to the suture material
Incidence of Suture removal due to adverse events
时间窗: until 3 months post-operatively
Cumulated frequency of adverse events
时间窗: until 3 months postoperatively
(edema, allergic reaction, ulceration, bleeding, granuloma, swelling, recurrence, reoperation, dry eyes)
Discomfort (VAS)
时间窗: until 3 months postoperatively
Patient satisfaction (VAS)
时间窗: until 3 months postoperatively
Handling of the suture
时间窗: 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).
次要结局
未报告次要终点