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.
试验速览
- 阶段
- Unknown
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Proportion of participants with treatment emergent adverse events during the study
研究概览
简要总结
This is a prospective, multi-center, single arm, Phase IV study, designed 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.
Patients with acute or chronic full thickness wounds, including deep-partial burns will be identified. The study wound will be identified (1 wound per patient) and debridement will be done. Two applications of Endoform™ Antimicrobial Dermal Template will be applied per week. The device can be applied for a minimum one week and maximum two weeks as per Investigator’s discretion. After that, if required, debridement will be done. One application of Endoform™ Natural Dermal Template will be done for one week. After a week of its application, surgical placement of Myriad Matrix™ will be done.
The study will commence only after obtaining written approval from the Indian Regulatory (Central Drugs Standard Control Organization) and site Institutional Ethics Committee.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients will be considered eligible for the study based on the following criteria:
- •Willing and able to provide written informed consent and to comply with the requirements of Clinical Investigational Plan
- •Male or female patients aged 18 years or above
- •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:
- •Patients with known sensitivity to ovine (sheep) derived material
- •Patients with known sensitivity to ionic silver
- •Patients with third degree burns
- •Patients with wounds with uncontrolled clinical infection (CDC Contamination Grade equal to 4), acute inflammation, excessive exudate, or bleeding
- •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
- •Patient is currently participating or has participated in another clinical study within past 30 days prior to enrollment
- •Pregnant or lactating women
- •Patients with suspected signs and symptoms of COVID-19 Or confirmed novel coronavirus infection (COVID-19).
结局指标
主要结局
Proportion of participants with treatment emergent adverse events during the study
时间窗: Minimum 03 weeks’ time required to confirm wound assessment and imaging from baseline to wound closure.
次要结局
- Proportion (%) of participants with complete wound closure (defined as 100%(skin re-epithelialization without drainage or dressing requirements, confirmed at 2 week follow-up))