Prospective PuraPly™ AM Case Series Study

NCT03070925 | Completed FDA Device

• 1 other identifier: 16-AW-002-PPAM
• Study Type: observational
• Target: 43
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Antimicrobial; Collagen; Bioburden; Biofilm; PHMB; Chronic wounds; Acute wounds

Outcome Measures

Primary Outcomes (1)

• Improvement in wound bed condition

  As measured from change in status from baseline

  12 Weeks

Interventions

PuraPly™ Antimicrobial Wound Matrix DEVICE

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.

Also known as: PuraPly™ Antimicrobial, PuraPly™ AM

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• Participant has a known sensitivity to porcine materials
• Participant has a third-degree burn
• Participant has a known sensitivity to polyhexamethylene biguanide hydrochloride (PHMB)
• Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products

Sponsors & Collaborators

• Organogenesis: lead

Study Sites (1)

Northwell Health, Inc

Lake Success, New York, 11402, United States

Location

MeSH Terms

Conditions

Pressure Ulcer; Varicose Ulcer; Surgical Wound

Condition Hierarchy (Ancestors)

Skin Ulcer; Skin Diseases; Skin and Connective Tissue Diseases; Varicose Veins; Vascular Diseases; Cardiovascular Diseases; Leg Ulcer; Wounds and Injuries

Study Officials

• Alisha Oropallo, MD

  Northwell Health, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2016
• First Posted: March 6, 2017
• Study Start: November 1, 2016
• Primary Completion: April 1, 2017
• Study Completion: May 1, 2017
• Last Updated: August 31, 2017

Record last verified: 2017-08

Locations

US (1)