MedTrace Logo

Prospective PuraPly™ AM Case Series Study

NCT03070925 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 43

Last updated 2017-08-31

No results posted yet for this study

Summary

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.

Conditions

  • Pressure Ulcers
  • Venous Ulcers
  • Diabetic Ulcers
  • Surgical Wounds
  • Trauma Wounds

Interventions

DEVICE

PuraPly™ Antimicrobial Wound Matrix

PuraPly AM consists of a collagen sheet coated with polyhexamethylene biguanide 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.

Sponsors & Collaborators

  • Organogenesis

    lead INDUSTRY

Principal Investigators

  • Alisha Oropallo, MD · Northwell Health, Inc.

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2017-04-30
Completion
2017-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03070925 on ClinicalTrials.gov