Prospective PuraPly™ AM Case Series Study

August 29, 2017 updated by: Organogenesis

A Prospective, Observational Study of the Use of PuraPly™ Antimicrobial (PuraPly AM) in the Management of Wounds

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

Study Overview

Status

Completed

Conditions

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

Observational

Enrollment (Actual)

43

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • Lake Success, New York, United States, 11402
        • Northwell Health, Inc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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 including the management of bioburden, support of granulation tissue formation, and support of wound closure.

Description

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)
    • Trauma wounds (abrasions, lacerations, second-degree burns, skin tears)
    • 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 polyhexamethylene biguanide hydrochloride (PHMB)
  4. Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

This is where you will find people and organizations involved with this study.

Sponsor

Organogenesis

Investigators

  • Principal Investigator: Alisha Oropallo, MD, Northwell Health, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2016

Primary Completion (ACTUAL)

April 1, 2017

Study Completion (ACTUAL)

May 1, 2017

Study Registration Dates

First Submitted

December 2, 2016

First Submitted That Met QC Criteria

March 3, 2017

First Posted (ACTUAL)

March 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

August 31, 2017

Last Update Submitted That Met QC Criteria

August 29, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16-AW-002-PPAM

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

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

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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