Prospective, multi-center, single-arm, interventional, post-market clinical study to evaluate safety and performance of absorbable, gelatin-based hemostat in patients undergoing abdominal, anorectal, dental, ENT, Genito-urinary, gynecological, hysterectomy, neurosurgery, orthopaedic, otolaryngological, partial nephrectomy, plastic surgery, cardiovascular, spinal, tumor surgery, hepatic or ophthalmic surgery when controlling bleeding by standard surgical techniques is ineffective and/or impractical
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Determination of Time to Hemostasis (TTH) Time Frame Day 0 Surgery
研究概览
简要总结
To evaluate safety and performance of absorbable, gelatin based hemostat in patients undergoing abdominal, anorectal dental ENT Genitourinary gynecological hysterectomy, neurosurgery orthopaedic otolaryngological, partial nephrectomy, plastic surgery cardiovascular spinal, tumor surgery hepatic or ophthalmic surgery when controlling bleeding by standard surgical techniques is ineffective and or impractical
The study will be conducted in compliance with local regulatory requirements. An Independent Ethics Committee will review and approve study related documents prior to patient enrolment. Patients will be screened as per pre-defined eligibility criteria. Patients who meet eligibility criteria will be explained the study procedure by principal investigator. Patients will sign informed consent before participating in the study
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •The patient is 18 years of age or older
- •The patient will undergo one or more of the following procedures: abdominal, anorectal, dental, ENT, Genito-urinary,gynecological, hysterectomy, neurosurgery, orthopaedic, otolaryngological, partial nephrectomy, plastic surgery, cardiovascular, spinal, tumor surgery, hepatic or ophthalmic surgery
- •Patient or their guardian is willing to sign Informed Consent Form (ICF)
- •Patient is willing to comply with the requirements given in ICF including the requirements for participating till last follow-up.
排除标准
- •Patient is known or suspected to be pregnant (verified in a manner consistent with institutions standard of care) or is lactating Patient is allergic to collagen derived products or any other materials used in absorbable gelatine sponge and powder Patient has an active infection at the surgical site The use of hemostat is contraindicated for the patient Patient has known bleeding disorder (including thrombocytopenia (less than 100000 platelet count) thrombasthenia hemophilia or von Willebrand disease) Patient has received antibiotic solutions or powders at the intended application site Patient has undergone surgery at the intended application site less than or equal to 6 months before the current surgical procedure Patient is unavailable for followup Patient is currently participating in another clinical study.
结局指标
主要结局
Determination of Time to Hemostasis (TTH) Time Frame Day 0 Surgery
时间窗: Determination of Time to Hemostasis (TTH) Time Frame Day 0 Surgery | Proportion of wounds achieving hemostasis at every 3rd minute, 6th minute and 10th minute after the application of absorbable gelatine sponge and powder
Proportion of wounds achieving hemostasis at every 3rd minute, 6th minute and 10th minute after the application of absorbable gelatine sponge and powder
时间窗: Determination of Time to Hemostasis (TTH) Time Frame Day 0 Surgery | Proportion of wounds achieving hemostasis at every 3rd minute, 6th minute and 10th minute after the application of absorbable gelatine sponge and powder
次要结局
- Hemostatic Handling Characteristics (Surgeon s Questionnaire) Time Frame Day 0 Surgery(Determination of handling characteristics of absorbable gelatine sponge and powder during implantation)
研究者
Dr Peeyusha Wadhwani Rajani
Medical Care Centre and Hospital