Pressure Ulcer Clinical Trial
Official title:
Real-World Effectiveness Study of PuraPly™ AM on Wounds
The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.
The purpose of this study is to assess the impact of PuraPly™ AM on the management of wounds
in real world clinical settings as it leads to an improvement in wound bed condition (i.e
increase in healthy granulation tissue, reduction in bioburden, and reduction in amount of
exudate).
The RESPOND Registry is a prospective, non-interventional research initiative to collect
information on patients who are eligible to receive PuraPly™ AM, and no interventional
procedures will be mandated by this protocol.
Enrolled and eligible patients will receive standard wound care clinical assessments and any
additional care as determined by the treating wound care clinician. Although multiple wounds
may be treated simultaneously, one wound will be identified as the target wound, and
characteristics regarding this wound will be consistently documented.
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 24 weeks following
application of PuraPly™ AM.
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