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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. Read our disclaimer for details. Identifier: NCT03502824
Recruitment Status : Active, not recruiting
First Posted : April 19, 2018
Last Update Posted : February 18, 2020
Information provided by (Responsible Party):

Brief Summary:
This is a prospective, multi-center, 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 located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.

Condition or disease Intervention/treatment Phase
Chronic Pressure Ulcers Device: PuraPly® Antimicrobial Wound Matrix Other: SOC for Pressure Ulcers Not Applicable

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : May 1, 2018
Estimated Primary Completion Date : March 15, 2020
Estimated Study Completion Date : March 15, 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. Reduction in size of ulcer area between groups [ Time Frame: Up to 24 weeks ]
    As measured from change in size from baseline

  2. Improvement in wound bed condition between groups [ Time Frame: Up to 24 weeks ]
    As measured from change in status from baseline

Secondary Outcome Measures :
  1. Time to complete wound closure between both groups [ Time Frame: Up to 24 weeks ]
    As measured by time to complete wound closure from baseline

  2. 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)

  3. 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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Subject must be at least 18 years of age.
  2. Subject has a Stage II-IV pressure ulcer located in the gluteal, ischial, hip, sacral, coccygeal, and trochanteric, malleolus, or heel area.
  3. Pressure ulcer should be present for 4 weeks duration and have a ulcer surface area > 2cm2
  4. If multiple ulcers are present, one ulcer must be identified as the index ulcer.
  5. The index ulcer is free from active infection at the time of randomization.
  6. Willingness to off-load or pressure redistribute ulcer for duration of enrollment
  7. The index ulcer has been offloaded for at least 7 days prior to randomization.
  8. The index ulcer must have been present for at least 30 days at time of study enrollment.
  9. The index ulcer is separated at least 4 cm from all other ulcers at Study Day -7 and Study Day 0 (post-debridement) and has a margin of intact skin sufficient for anchoring of the required study dressing.
  10. Subject has read and signed the IRB/IEC approved Informed Consent Form (ICF) before screening procedures are undertaken.

Exclusion Criteria:

  1. Presence of signs and symptoms of infection at the index ulcer site, including but not limited to cellulitis, acute osteomyelitis, excessive exudate, gangrene or deep tissue infection
  2. The index ulcer is not free of necrotic tissue and is unable to tolerate debridement
  3. Non-enteric or unexplored sinus tract
  4. Concomitant conditions that in the judgment of the investigator would make the subject inappropriate for entry to the study
  5. Subject has a known sensitivity to porcine materials
  6. Subject has a known sensitivity to polyhexamethylenebiguanide (PHMB)

Information from the National Library of Medicine

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 identifier (NCT number): NCT03502824

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United States, New York
Northwell Health
Lake Success, New York, United States, 11402
NYU Winthrop Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
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Principal Investigator: Scott Gorenstein, MD FACEP NYU Winthrop Hospital
Principal Investigator: Alisha Oropallo, MD, FACS, APWCA Northwell Health

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Responsible Party: Organogenesis Identifier: NCT03502824    
Other Study ID Numbers: 17-PRU-004-PPAM
First Posted: April 19, 2018    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Organogenesis:
Chronic wounds
Pressure Ulcer
Wound Management
Stage II
Stage III
Stage IV
Pressure Injury
Additional relevant MeSH terms:
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Pressure Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Anti-Bacterial Agents
Anti-Infective Agents