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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
Sponsor:
Information provided by (Responsible Party):
Organogenesis

Brief Summary:
The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylenbiguanide hydrochloride (PHMB) and is intended for the management of wounds; no experimental intervention is involved.

Condition or disease Intervention/treatment
Pressure Ulcer Venous Ulcer Diabetic Ulcer Surgical Wound Trauma Wound Device: PuraPly™ Antimicrobial Wound Matrix

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 : Observational
Actual Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Device: PuraPly™ Antimicrobial Wound Matrix
    PuraPly AM consists of a collagen sheet coated with polyhexamethylenbiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly AM is supplied dry in sheet form. The device is packaged in sterile, sealed single patches.
    Other Name: PuraPly AM


Primary Outcome Measures :
  1. Improvement in wound bed condition [ Time Frame: 12 Weeks ]
    As measured from change in status from baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Eligible patients are men and women at least 18 years old, with an eligible target wound that meets the Investigator's wound specific treatment goals that include the management of bioburden, support of granulation tissue formation and support of wound closure.
Criteria

Inclusion Criteria:

  1. Participant is at least 18 years of age
  2. Participant has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).
  3. 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:

  1. Participant has a known sensitivity to porcine materials
  2. Participant has a third-degree burn
  3. Participant has a known sensitivity to polyhexamethylenbiguanide hydrochloride (PHMB)
  4. Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products

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 ClinicalTrials.gov identifier (NCT number): NCT03070938


Locations
United States, New York
Winthrop University Hospital
Mineola, New York, United States, 11501
Sponsors and Collaborators
Organogenesis
Investigators
Principal Investigator: Scott Gorenstein, MD Winthrop University Hospital/ Winthrop Wound Healing Center

Responsible Party: Organogenesis
ClinicalTrials.gov Identifier: NCT03070938     History of Changes
Other Study ID Numbers: PuraPly AM Case Series
First Posted: March 6, 2017    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Organogenesis:
Chronic wounds
Acute Wounds
PHMB
Wound Management
Bioburden
Collagen

Additional relevant MeSH terms:
Wounds and Injuries
Ulcer
Pressure Ulcer
Surgical Wound
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Anti-Infective Agents
Anti-Bacterial Agents