Status:
COMPLETED
The RESPOND Registry
Lead Sponsor:
Organogenesis
Collaborating Sponsors:
Continuum Clinical Inc.
Conditions:
Partial Thickness Wound
Pressure Ulcer
Eligibility:
All Genders
18+ years
Brief Summary
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.
Detailed Description
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 healt...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 21 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 26 2019
Estimated Enrollment :
310 Patients enrolled
Trial Details
Trial ID
NCT03286452
Start Date
February 21 2017
End Date
January 26 2019
Last Update
February 27 2019
Active Locations (15)
Enter a location and click search to find clinical trials sorted by distance.
1
Advanced Wound Care Center at Yavapai Regional Medical Center
Prescott Valley, Arizona, United States, 86314
2
Jupiter Medical Center
Jupiter, Florida, United States, 33458
3
West Gables Rehab Hospital
Miami, Florida, United States, 33155
4
Institute for Advanced Wound Healing; Northshore Specialty Hospital
Covington, Louisiana, United States, 70433