PuraPly™ Antimicrobial Wound Matrix and Wound Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-10-31

Brief Summary

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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

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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

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Pressure Ulcer Venous Ulcer Diabetic Ulcer Surgical Wound Trauma Wound

Keywords

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Chronic wounds Acute Wounds PHMB Wound Management Bioburden Collagen

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

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PuraPly™ 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.

Intervention Type DEVICE

Other Intervention Names

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PuraPly AM

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Scott Gorenstein, MD

Role: PRINCIPAL_INVESTIGATOR

Winthrop University Hospital/ Winthrop Wound Healing Center

Locations

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Winthrop University Hospital

Mineola, New York, United States

Site Status

Countries

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United States

Other Identifiers

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PuraPly AM Case Series

Identifier Type: -

Identifier Source: org_study_id