Prospective PuraPly™ AM Case Series Study

Status Completed

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03070925
Study type	Observational
Source	Organogenesis
Contact
Status	Completed
Phase	N/A
Start date	November 2016
Completion date	May 2017

View Details

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