PuraPly™ Antimicrobial Wound Matrix and Wound Management

Organogenesis100 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

100

Conditions

Pressure Ulcer Venous Ulcer Diabetic Ulcer Surgical Wound Trauma Wound

Interventions

PuraPly™ Antimicrobial Wound MatrixDEVICE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Participant is at least 18 years of age 2. Participant has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF). 3. 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 Exclusion Criteria: 1. Participant has a known sensitivity to porcine materials 2. Participant has a third-degree burn 3. Participant has a known sensitivity to polyhexamethylenbiguanide hydrochloride (PHMB) 4. Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products

Locations (1)

Winthrop University Hospital

Mineola, New York, United States

Outcomes

Primary Outcomes

Improvement in wound bed condition

As measured from change in status from baseline

Time frame: 12 Weeks

Data from ClinicalTrials.gov

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