PuraPly™ Antimicrobial Wound Matrix and Wound Management (PuraPlyAM)
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|ClinicalTrials.gov Identifier: NCT03070938|
Recruitment Status : Completed
First Posted : March 6, 2017
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment|
|Pressure Ulcer Venous Ulcer Diabetic Ulcer Surgical Wound Trauma Wound||Device: PuraPly™ Antimicrobial Wound Matrix|
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 :||Observational|
|Actual Enrollment :||100 participants|
|Official Title:||A Prospective, Observational Study of the Use of PuraPly™ Antimicrobial in the Management of Wounds|
|Actual Study Start Date :||November 2016|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||October 2017|
Device: PuraPly™ Antimicrobial Wound Matrix
- Improvement in wound bed condition [ Time Frame: 12 Weeks ]As measured from change in status from baseline
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070938
|United States, New York|
|Winthrop University Hospital|
|Mineola, New York, United States, 11501|
|Principal Investigator:||Scott Gorenstein, MD||Winthrop University Hospital/ Winthrop Wound Healing Center|