NCT03070925

Prospective PuraPly™ AM Case Series Study

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 43 (actual)
• Sponsor: Organogenesis · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2016-11-01
• Primary completion: 2017-04-01
• Completion: 2017-05-01
• First posted: 2017-03-06
• Last updated: 2017-08-31

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study