Real-World Effectiveness Study of PuraPly™ AM on Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 310
- 试验地点
- 15
- 主要终点
- Reduction in size of wound area
研究概览
简要总结
The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.
详细描述
The purpose of this study is to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings as it leads to an improvement in wound bed condition (i.e increase in healthy granulation tissue, reduction in bioburden, and reduction in amount of exudate).
The RESPOND Registry is a prospective, non-interventional research initiative to collect information on patients who are eligible to receive PuraPly™ AM, and no interventional procedures will be mandated by this protocol.
Enrolled and eligible patients will receive standard wound care clinical assessments and any additional care as determined by the treating wound care clinician. Although multiple wounds may be treated simultaneously, one wound will be identified as the target wound, and characteristics regarding this wound will be consistently documented.
The case series is being undertaken to better understand PuraPly™ AM utilization and subsequent healing outcomes as well as to evaluate the effects of concomitant wound therapy on healing. Patient's participation may involve follow-up for up to 24 weeks following application of PuraPly™ AM.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient is at least 18 years of age.
- •Patient, or their legally authorized representative (LAR), has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- •Patient has a wound appropriate for receiving PuraPly™ AM, including:
- •Partial or full-thickness wound
- •Pressure ulcer
- •Venous ulcer
- •Diabetic ulcer
- •Chronic vascular ulcer
- •Tunneled/undermined wound
- •Surgical wound (e.g., donor sites/graft, post-Mohs' surgery, post-laser surgery, podiatric surgery wound, wound dehiscence)
- •Trauma wound (abrasions, lacerations, second degree burns, and skin tears)
- •Draining wound
排除标准
- •Patient has a known sensitivity to porcine materials.
- •Patient has a third-degree burn.
- •Patient has a known sensitivity to polyhexamethylenebiguanide hydrochloride (PHMB).
- •Patient's target wound was previously treated with PuraPly™ AM.
结局指标
主要结局
Reduction in size of wound area
时间窗: Up to 24 weeks
As measured from change in size from baseline
Time to complete wound closure
时间窗: Up to 24 weeks
As measured by time to complete wound closure from baseline
Improvement in wound bed condition
时间窗: Up to 24 weeks
As measured from change in status from baseline
次要结局
- Improvement in patient reported pain(Up to 24 weeks)
- Improvement in patient reported quality of life(Up to 24 weeks)