The RESPOND Registry

Completed

Conditions studied: Partial Thickness Wound, Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, Surgical Wounds, Trauma Wounds, Draining Wounds, Chronic Vascular Ulcer

In brief

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.

Key facts

Study ID

NCT03286452

Run by

Organogenesis

People needed

310

Starts

2017-02-21

Expected to finish

2019-01-26

Last updated by the study team

2019-02-27

Who can join

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

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Advanced Wound Care Center at Yavapai Regional Medical Center — Prescott Valley, Arizona, United States
• Jupiter Medical Center — Jupiter, Florida, United States
• West Gables Rehab Hospital — Miami, Florida, United States
• Institute for Advanced Wound Healing; Northshore Specialty Hospital — Covington, Louisiana, United States
• Wound Care Associates, LLC. — Hammond, Louisiana, United States
• Opelousas General Hospital Wound Center — Opelousas, Louisiana, United States
• Saint Louis Foot and Ankle — St Louis, Missouri, United States
• CentraState Medical Center — Freehold, New Jersey, United States
• Robert Wood Johnson Hamilton — Hamilton, New Jersey, United States
• Southampton Hospital — Southampton, New York, United States
• Wayne Memorial Hospital — Goldsboro, North Carolina, United States
• Sacred Heart Hospital — Allentown, Pennsylvania, United States
• Harrisburg Foot and Ankle Center, Inc. — Harrisburg, Pennsylvania, United States
• Greensville Health System — Greenville, South Carolina, United States
• Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute — Madison, Wisconsin, United States

Full record on ClinicalTrials.gov

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