A Single-Center, Prospective, Open label, Single Arm, Post market Surveillance Study to Evaluate the Safety & Efficacy of Sterile Oxidized Regenerated Cellulose Hemostat (ORCH), Represented By The Brand Names OxidoRCEL, XEALANTA, clotoRCEL and COAGULO-Rx for Bleeding Control During Elective Intraoperative Procedures & Traumatic Bleeding situations
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- 1. Number of participants with Adverse events
研究概览
简要总结
Blood is a fluid that transports oxygen and nutrients to the cells and carries away carbon dioxide and other waste products. Technically, blood is a transport liquid pumped by the heart (or an equivalent structure) to all parts of the body, after which it is returned to the heart to repeat the process. Blood is an opaque red fluid, freely flowing but denser and more viscous than water.
Thrombocytes are also called platelets and are cell fragments which circulate within the blood with a life span of about 10 days. Platelets are anucleate disk-shaped cells, 2–4 μm in diameter. The normal platelet count is 150,000–400,000 per cubic millimeter or 150–400 × 109 platelets per liter.
Hemostasis:
Hemostasis is the process by which the body seals a ruptured blood vessel and prevents further loss of blood.
Hemostasis or bleeding control during elective & traumatic surgical procedures is essentially aimed at controlling vascular leakage with the support of pro-hemostatic agents, tools or methods in order to preserve the blood as well as to create a visually clear operating field for further downstream “procedures or for the closure of surgical siteâ€. An effective hemostatic agent or tool essentially prevents the bleeding within the stipulated time and on further application prevents minor capillary oozing or leakage that may happen during downstream procedures or during recovery period. Oxidized Regenerated Cellulose Hemostat is an effective bleeding control agent and is recommended when other conventional bleeding control agents are either ineffective or difficult to apply.
RATIONALE FOR CONDUCTING THIS STUDY
Sterile Oxidized Regenerated Cellulose Hemostat has traditionally been used for surgical bleeding control where application of conventional bleeding control procedures including electro cauterization or other ligature techniques is impractical or not effective due to specific anatomic and physiological reasons.
Oxidized regenerated cellulose hemostats represent an important class of biocompatible and bioabsorbable polymers, and they have been available in a sterilized knitted fabric, non-woven fluffy or powder form for surgical hemostasis. Oxidized regenerated cellulose hemostat is a white or pale yellow in color and can be cut into desired sizes for different surgeries. It is useful for all types of surgeries where intra-operative bleeding is anticipated or encountered such as procedures in General& Colorectal surgery, Gynecology & genitourinary surgeries, Orthopedic surgery, Oncological surgery, Colon surgery, Neurosurgery and CVTS etc., to name a few. Oxidized regenerated cellulose is an absorbable hemostat and is fully resorbable from the site of application within stipulated time.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 69.00 Year(s)（—）
- 性别
- All
入选标准
- •Male/females of 18 years of age or older
- •Patient who can and willing to provide written Informed Consent
- •Patients with life expectancy of at least one year Intra-Operative inclusion criteria
- •Patients with mild or moderate bleeding/oozing during elective surgical procedures where control of bleeding is difficult/ ineffective with conventional procedures.
- •Absence of intra-operative complications other than bleeding which, in the opinion of the investigator, may interfere with the assessment of efficacy or safety
- •No active or suspected infection at the pre-defined surgical site/area
- •Approximate Target Bleeding Site of no more than 15cm length.
排除标准
- •1.Patient having a mental or physical condition that would, in the opinion of the investigator, place the subject at an unacceptable risk or render the subject unable to meet the requirements of the protocol
- •Patient has participated in another clinical study involving another investigational agent within 4 weeks of the start of this trial, or is planning participation in another clinical trial during the current study duration
- •Patient with any type of coagulation disorders including thrombocytopenia that may interfere with the assessment of efficacy or pose a safety risk to the subject according to the investigator
- •Patient having has a clinically significant coagulation disorder or disease, platelets less than 10 multiplied by 10 to the power of 9 per L during screening
- •Patient with activated partial thromboplastin time (aPTT) greater than 100 seconds during screening
- •Patient with International Normalized Ratio (INR)greater than 2.5 during screening
- •Patient receiving antiplatelet medications within 5 days prior to surgery
- •Patient has a documented severe congenital or acquired Immunodeficiency.
结局指标
主要结局
1. Number of participants with Adverse events
时间窗: 1 week
2. Absence of immediate surgical site swelling/ inflammation
时间窗: 1 week
3. Absence of vessel rupture and concurrent increase in bleeding
时间窗: 1 week
4. Absence of increase in bleeding levels without vessel rupture
时间窗: 1 week
5. Absence of additional bleeding (proximal to the original bleeding site/ within the
时间窗: 1 week
surgical field)
时间窗: 1 week
次要结局
- 1.Mean Time to Hemostasis(Time to achieve hemostats is will be recorded in minutes from the first application of study treatment until cessation of bleeding)
研究者
Dr J Sridhar
Vinayaka Mission’s Kirupananda Variyar Medical College & Hospital