Prospective PuraPly™ AM Case Series Study

Completed

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

In brief

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.

Key facts

Study ID

NCT03070925

Run by

Organogenesis

People needed

43

Starts

2016-11-01

Expected to finish

2017-05-01

Last updated by the study team

2017-08-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Northwell Health, Inc — Lake Success, New York, United States

Full record on ClinicalTrials.gov

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