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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.
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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PuraPlyâ„¢ Antimicrobial Wound Matrix | Device | PuraPly AM consists of a collagen sheet coated with polyhexamethylenbiguanide 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in wound bed condition | As measured from change in status from baseline | 12 Weeks |
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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
Exclusion Criteria:
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Eligible patients are men and women at least 18 years old, with an eligible target wound that meets the Investigator's wound specific treatment goals that include the management of bioburden, support of granulation tissue formation and support of wound closure.
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| Name | Affiliation | Role |
|---|---|---|
| Scott Gorenstein, MD | Winthrop University Hospital/ Winthrop Wound Healing Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Winthrop University Hospital | Mineola | New York | 11501 | United States |
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| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014647 | Varicose Ulcer |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014648 | Varicose Veins |
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| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D014947 | Wounds and Injuries |