The RESPOND Registry



Status:Completed
Conditions:Skin and Soft Tissue Infections, Cardiology, Hospital, Gastrointestinal
Therapuetic Areas:Cardiology / Vascular Diseases, Dermatology / Plastic Surgery, Gastroenterology, Other
Healthy:No
Age Range:18 - Any
Updated:3/1/2019
Start Date:February 21, 2017
End Date:January 26, 2019

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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.

Inclusion Criteria:

- Patient is at least 18 years of age.

- Patient, or their legally authorized representative (LAR), has read, understood and
signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).

- Patient has a wound appropriate for receiving PuraPly™ AM, including:

- Partial or full-thickness wound

- Pressure ulcer

- Venous ulcer

- Diabetic ulcer

- Chronic vascular ulcer

- Tunneled/undermined wound

- Surgical wound (e.g., donor sites/graft, post-Mohs' surgery, post-laser surgery,
podiatric surgery wound, wound dehiscence)

- Trauma wound (abrasions, lacerations, second degree burns, and skin tears)

- Draining wound

Exclusion Criteria:

- Patient has a known sensitivity to porcine materials.

- Patient has a third-degree burn.

- Patient has a known sensitivity to polyhexamethylenebiguanide hydrochloride (PHMB).

- Patient's target wound was previously treated with PuraPly™ AM.
We found this trial at
15
sites
Miami, Florida 33155
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Miami, FL
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Jupiter, Florida 33458
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Jupiter, FL
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Allentown, Pennsylvania 18102
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Allentown, PA
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Covington, LA
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Freehold, New Jersey 07728
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Freehold, NJ
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2700 Wayne Memorial Dr
Goldsboro, North Carolina 27534
(919) 736-1110
Wayne Memorial Hospital Wayne Memorial Hospital, an affiliate of Wayne Health Corporation, is home to...
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Goldsboro, NC
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Greenville, South Carolina 29605
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Greenville, SC
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Hamilton, New Jersey 08690
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Hamilton, NJ
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Hammond, Louisiana 70403
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Hammond, LA
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Harrisburg, Pennsylvania 17112
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Harrisburg, PA
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Madison, WI
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Opelousas, Louisiana 70570
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Opelousas, LA
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Prescott Valley, AZ
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Saint Louis, Missouri 63128
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Saint Louis, MO
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Southampton, New York 11968
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Southampton, NY
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