A prospective, open label, multi-center, single-arm, observational post-market clinical follow-up registry study to evaluate the safety and performance of absorbable, oxidized regenerated cellulose hemostat - Surgi-ORC®.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 107
- 试验地点
- 2
- 主要终点
- Determination of Time to Heamostasis (TTH) Time Frame Day 0 Surgery-Proportion of wounds achieving hemostasis at every 2 minutes, 5 minutes and 10 minutes after the application of Surgi-ORC.
研究概览
简要总结
Study Design: Prospective, multi-center, single-arm, observational, post-market clinical follow-up registry study.
Study Population: Patients undergoing following surgeries:
Abdominal Surgery, Gynecological Surgery, Partial Nephrectomy, Anorectal Surgery, Hysterectomy, Plastic Surgery, Dental Surgery, Neuro Surgery, Cardiovascular Surgery, ENT surgery, Orthopedic Surgery, Spinal Surgery, Genito Urinary Surgery, Otolaryngological Surgery, Tumor Surgery, Hepatic Surgery, Ophthalmic Surgery, Cardiothoracic Surgery, General Surgery, Obstetrics Surgery, Urologic Surgery.
No. of Study Subject: 107
No. of Study Sites: Minimum 2 sites
Subject Device: Oxidized Regenerated Cellulose Haemostats:
1. Surgi-ORC® Original / Standard,
2. Surgi-ORC® Fibril,
3. Surgi-ORC® Knit and
4. Surgi-ORC® Non-woven/SNOW
5. Surgi-ORC® Powde
Study Duration: 60 days
Study Schedule: Study schedule includes pre-operative evaluation, operative day (0 day) and four follow-ups.
The follow-up days will include 2nd day, 28th day, and 60th day after surgery
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Used in all except those who are having known allergy to cellulose
- •Patient or their LDR is willing to sign Informed Consent Form (ICF)
- •Patients undergoing following surgeries: Abdominal Surgery, Gynecological Surgery, Partial Nephrectomy, Anorectal Surgery, Hysterectomy, Plastic Surgery, Dental Surgery, Neuro Surgery, Cardiovascular Surgery, ENT surgery, Orthopedic Surgery, Spinal Surgery, Genito Urinary Surgery, Otolaryngological Surgery, Tumor Surgery, Hepatic Surgery, Ophthalmic Surgery, Cardiothoracic Surgery, General Surgery, Obstetrics Surgery, Urologic Surgery.
- •Patient is willing to comply with the requirements given in ICF including the requirements for participating till last follow-up.
排除标准
- •Haemostat to be used for packing and wadding without removal after hemostasis is achieved.
- •Haemostat to be used for implantation in bone defects, such as fractures, which may interfere with callus formation and may cause cyst formation.
- •Removal of haemostat is not possible after achieving hemostasis in or around foramina in bone, areas of bony confine, the spinal cord or the optic nerve and chiasm.
- •Hemostasis is required for hemorrhage from large arteries.
- •Treatment non hemorrhagic serious oozing surfaces, since body fluids, except whole blood, such as serum, do not react with Surgi ORC Haemostat to give satisfactory result.
- •Haemostat is required as adhesion prevention product.
- •Patients with known hypersensitivity of Cellulose.
- •Hemostasis is required in open blood vessel.
- •Patient is known or suspected to be pregnant (verified in a manner consistent with institutions standard of care), or is lactating.
- •Patient has known bleeding disorder (including thrombocytopenia [less than 100,000 platelet count], thrombobasthenia, haemophilia, or von Willebrand disease)
- •Patient has received antibiotic solutions or powders at the intended application site.
- •Patient is unavailable for follow-up.
- •Patient is currently participating in another clinical study.
结局指标
主要结局
Determination of Time to Heamostasis (TTH) Time Frame Day 0 Surgery-Proportion of wounds achieving hemostasis at every 2 minutes, 5 minutes and 10 minutes after the application of Surgi-ORC.
时间窗: Pre-Operative, Operative Day 0, Day 2, Day 28, Day 60.
次要结局
- 1 Hemostatic Handling Characteristics Surgeons Questionnaire Time Frame Day 0 Surgery Determination of handling characteristics of Surgi-ORC during its implantation.(2 Liquefication of Surgi-ORC Time Frame Day 2 post-Procedure Determination of initiation of absorption of Surgi-ORC through radiological examination after 2 days of its implantation.)
研究者
Dr Abhinav Bhatnagar
Abhinav Multispecialty Hospital.