CTRI/2022/01/039714招募中4 期
A prospective, multi-center, single arm, post-marketing study to evaluate the safety and efficacy of Ovine Forestomach Matrix (OFM) products (Endoformâ?¢ Natural Dermal Template; Endoformâ?¢ Antimicrobial Dermal Template and Myriad Matrixâ?¢) in acute or chronic wound. - NA
试验速览
- 阶段
- 4 期
- 状态
- 招募中
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Pms
入排标准
入选标准
- •Patients will be considered eligible for the study based on the following criteria:
- •1. Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan
- •2. Male or female patients aged 18 years or above
- •3. Patients with acute or chronic full thickness wounds, including deep partial burns
排除标准
- •Patients will be excluded from the study based on the following criteria:
- •1. Patients with known sensitivity to ovine (sheep) derived material
- •2. Patients with known sensitivity to ionic silver
- •3. Patients with third degree burns
- •4. Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade equal to 4), acute inflammation, excessive exudate, or bleeding
- •5. Any medical condition or serious intercurrent illness that, in the opinion of the investigator, may make it undesirable for the patient to participate in the study
- •6. Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment
- •7. Pregnant or lactating women
- •8. Patients with suspected signs and symptoms of COVID-19 Or confirmed novel coronavirus infection (COVID-19)
研究者
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