PuraPly® AM Plus the Standard of Care to Standard of Care Alone for the Management of Stage II-IV Pressure Ulcers.
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03502824|
Recruitment Status : Not yet recruiting
First Posted : April 19, 2018
Last Update Posted : April 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pressure Ulcers||Device: PuraPly® Antimicrobial Wound Matrix Other: SOC for Pressure Ulcers||Not Applicable|
This study seeks to demonstrate how PuraPly® AM performs against standard of care in Stage II-IV Pressure Ulcers through a prospective randomized controlled study design.
Subjects may be enrolled for up to 24 weeks; if healing occurs prior to week 24, a follow up healing confirmation visit shall occur two weeks later to confirm maintenance of complete wound closure and participation may continue up to 24 weeks. Subjects that are randomized to the SOC group have the opportunity to cross over and receive PuraPly AM at week 12 if their index ulcer has not healed; they will then be followed for an additional 12 weeks for up to 24 weeks.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Multicenter, Randomized, Controlled Clinical Study Of PuraPly® AM and Standard of Care (SOC) Compared to SOC Alone For The Management Of Stage II-IV Pressure Ulcers|
|Estimated Study Start Date :||April 2018|
|Estimated Primary Completion Date :||August 2018|
|Estimated Study Completion Date :||November 2018|
|Active Comparator: PuraPly® AM plus Standard of Care||
Device: PuraPly® Antimicrobial Wound Matrix
PuraPly® AM is a class II medical device, that has been 510(k) cleared by US Food and Drug Administration (FDA) (K051647) and is intended for the management of acute and chronic wound management across a variety of wound types, including partial- and full-thickness wounds, pressure ulcers, surgical wounds, trauma wounds, venous and diabetic ulcers.
Other Name: PuraPly® AM
|Active Comparator: Standard of Care (SOC) for Pressure Ulcers||
Other: SOC for Pressure Ulcers
SOC group will receive institutional standard of care which includes, but is not limited to, debridement, negative pressure wound therapy (i.e. VAC), ensuring perfusion and oxygenation, evaluating nutritional status and addressing deficits, offloading, keeping the ulcer bed moist with appropriate cleansing at the time of each dressing change. Standard dressings may include hydrocolloids, alginates, transparent film, foam, moist gauze dressings. In addition, a non-toxic topical antiseptic, may be used per NPUAP Clinical Practice Guidelines (2014) for SOC group only, if colonization is suspected.
- Reduction in size of ulcer area between groups [ Time Frame: Up to 24 weeks ]As measured from change in size from baseline
- Improvement in wound bed condition between groups [ Time Frame: Up to 24 weeks ]As measured from change in status from baseline
- Time to complete wound closure between both groups [ Time Frame: Up to 24 weeks ]As measured by time to complete wound closure from baseline
- Improvement in patient reported pain [ Time Frame: Up to 24 weeks ]As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)
- Improvement in patient reported quality of life [ Time Frame: Up to 24 weeks ]As measured by change in status from baseline as assessed by the Wound QoL (W-QoL), questionnaire on quality of life with chronic wounds
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): NCT03502824
|Contact: Santina Wendling||781-401-1147||Wendling@organo.com|
|Contact: Shabnam Vaezzadeh||(781) email@example.com|
|United States, New York|
|Northwell Health||Not yet recruiting|
|Lake Success, New York, United States, 11402|
|Contact: Sally Kaplan, RN, CCRC 516-562-4578 Skaplan2@northwell.edu|
|Principal Investigator: Alisha Oropallo, MD|
|NYU Winthrop Hospital||Active, not recruiting|
|Mineola, New York, United States, 11501|
|Principal Investigator:||Scott Gorenstein, MD FACEP||NYU Winthrop Hospital|
|Principal Investigator:||Alisha Oropallo, MD, FACS, APWCA||Northwell Health|