Prospective PuraPly™ AM Case Series Study

Pressure Ulcers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03070925
• Other study ID #: 16-AW-002-PPAM
• Status: Completed
• Phase: N/A
• First received: December 2, 2016
• Last updated: August 29, 2017
• Start date: November 2016
• Est. completion date: May 2017

Study information

• Verified date: August 2017
• Source: Organogenesis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: May 2017
• Est. primary completion date: April 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Ulcers
• Pressure Ulcer
• Pressure Ulcers
• Surgical Wounds
• Trauma Wounds
• Ulcer
• Varicose Ulcer
• Venous Ulcers
• Wounds and Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	Northwell Health, Inc	Lake Success	New York

Sponsors (1)

Lead Sponsor	Collaborator
Organogenesis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement in wound bed condition	As measured from change in status from baseline	12 Weeks