PuraPly™ Antimicrobial Wound Matrix and Wound Management

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03070938

Acronym

PuraPlyAM

Enrollment

100

Registered

2017-03-06

Start date

2016-11-30

Completion date

2017-10-31

Last updated

2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetic Ulcer, Pressure Ulcer, Surgical Wound, Trauma Wound, Venous Ulcer

Keywords

Chronic wounds, Acute Wounds, PHMB, Wound Management, Bioburden, Collagen

Brief summary

The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylenbiguanide 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.

Interventions

DEVICEPuraPly™ Antimicrobial Wound Matrix

PuraPly AM consists of a collagen sheet coated with polyhexamethylenbiguanide 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.

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026