Prospective PuraPly™ AM Case Series Study

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

43 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-11-30

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Pressure Ulcers Venous Ulcers Diabetic Ulcers Surgical Wounds Trauma Wounds

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Antimicrobial Collagen Bioburden Biofilm PHMB Chronic wounds Acute wounds

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

PuraPly™ Antimicrobial PuraPly™ AM

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alisha Oropallo, MD

Role: PRINCIPAL_INVESTIGATOR

Northwell Health, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Northwell Health, Inc

Lake Success, New York, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16-AW-002-PPAM

Identifier Type: -

Identifier Source: org_study_id