Prospective PuraPly™ AM Case Series Study

Study Overview
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Brief Summary
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The PuraPly AM case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) and is intended for the management of wounds; no experimental intervention is involved.

Detailed Description
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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.

Official Title
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A Prospective, Observational Study of the Use of PuraPly™ Antimicrobial (PuraPly AM) in the Management of Wounds

Conditions
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Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Surgical Wounds, Trauma Wounds

Intervention / Treatment
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* Device: PuraPly™ Antimicrobial Wound Matrix


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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) Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) Draining wounds Exclusion Criteria: Participant has a known sensitivity to porcine materials Participant has a third-degree burn Participant has a known sensitivity to polyhexamethylene biguanide hydrochloride (PHMB) Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PuraPly™ Antimicrobial Wound Matrix|PuraPly AM consists of a collagen sheet coated with polyhexamethylene biguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly AM is supplied dry in sheet form. The device is packaged in sterile, sealed single patches.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in wound bed condition | As measured from change in status from baseline | 12 Weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antimicrobial, Collagen, Bioburden, Biofilm, PHMB, Chronic wounds, Acute wounds