A Prospective, Observational Study of the Use of PuraPly™ Antimicrobial in the Management of Wounds
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Improvement in wound bed condition
研究概览
简要总结
The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylenbiguanide hydrochloride (PHMB) and is intended for the management of wounds; no experimental intervention is involved.
详细描述
The purpose of the case series is to assess the ability of PuraPly AM to meet wound specific treatment goals including management of bioburden, support of granulation tissue formation and support of wound closure. Patients will undergo clinical assessments and receive the standard of care as determined by the treating physician.
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 12 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
- •Participant is at least 18 years of age
- •Participant has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- •Participant has at least 1 wound appropriate for receiving PuraPly AM, including
- •Partial and full-thickness wounds
- •Pressure ulcers
- •Venous ulcers
- •Diabetic ulcers
- •Chronic vascular ulcers
- •Tunneled/undermined wounds
- •Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence) h. Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) i. Draining wounds
排除标准
- •Participant has a known sensitivity to porcine materials
- •Participant has a third-degree burn
- •Participant has a known sensitivity to polyhexamethylenbiguanide hydrochloride (PHMB)
- •Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products
结局指标
主要结局
Improvement in wound bed condition
时间窗: 12 Weeks
As measured from change in status from baseline
次要结局
未报告次要终点