- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03070938
PuraPly™ Antimicrobial Wound Matrix and Wound Management (PuraPlyAM)
A Prospective, Observational Study of the Use of PuraPly™ Antimicrobial in the Management of Wounds
Study Overview
Status
Intervention / Treatment
Detailed 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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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New York
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Mineola, New York, United States, 11501
- Winthrop University Hospital
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Participant is at least 18 years of age
- Participant has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).
Participant has at least 1 wound appropriate for receiving PuraPly AM, including
- Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
- Diabetic ulcers
- Chronic vascular ulcers
- Tunneled/undermined wounds
- Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence) h. Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) i. Draining wounds
Exclusion Criteria:
- Participant has a known sensitivity to porcine materials
- Participant has a third-degree burn
- Participant has a known sensitivity to polyhexamethylenbiguanide hydrochloride (PHMB)
- Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products
Study Plan
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Improvement in wound bed condition
Time Frame: 12 Weeks
|
As measured from change in status from baseline
|
12 Weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Scott Gorenstein, MD, Winthrop University Hospital/ Winthrop Wound Healing Center
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PuraPly AM Case Series
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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