The RESPOND Registry

Organogenesis310 enrolled

Overview

The RESPOND Registry is an observational study to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.

The purpose of this study is to assess the impact of PuraPly™ AM on the management of wounds in real world clinical settings as it leads to an improvement in wound bed condition (i.e increase in healthy granulation tissue, reduction in bioburden, and reduction in amount of exudate). The RESPOND Registry is a prospective, non-interventional research initiative to collect information on patients who are eligible to receive PuraPly™ AM, and no interventional procedures will be mandated by this protocol. Enrolled and eligible patients will receive standard wound care clinical assessments and any additional care as determined by the treating wound care clinician. Although multiple wounds may be treated simultaneously, one wound will be identified as the target wound, and characteristics regarding this wound will be consistently documented. 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 24 weeks following application of PuraPly™ AM.

Study Type

OBSERVATIONAL

Enrollment

310

Conditions

Partial Thickness Wound Pressure Ulcer Venous Ulcer Diabetic Ulcer Surgical Wounds Trauma Wounds Draining Wounds Chronic Vascular Ulcer

Interventions

PuraPly™ Antimicrobial Wound MatrixDEVICE

PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patient is at least 18 years of age. * Patient, or their legally authorized representative (LAR), has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF). * Patient has a wound appropriate for receiving PuraPly™ AM, including: * Partial or full-thickness wound * Pressure ulcer * Venous ulcer * Diabetic ulcer * Chronic vascular ulcer * Tunneled/undermined wound * Surgical wound (e.g., donor sites/graft, post-Mohs' surgery, post-laser surgery, podiatric surgery wound, wound dehiscence) * Trauma wound (abrasions, lacerations, second degree burns, and skin tears) * Draining wound Exclusion Criteria: * Patient has a known sensitivity to porcine materials. * Patient has a third-degree burn. * Patient has a known sensitivity to polyhexamethylenebiguanide hydrochloride (PHMB). * Patient's target wound was previously treated with PuraPly™ AM.

Locations (15)

Advanced Wound Care Center at Yavapai Regional Medical Center

Prescott Valley, Arizona, United States

Jupiter Medical Center

Jupiter, Florida, United States

Outcomes

Primary Outcomes

Reduction in size of wound area

As measured from change in size from baseline

Time frame: Up to 24 weeks

Time to complete wound closure

As measured by time to complete wound closure from baseline

Time frame: Up to 24 weeks

Improvement in wound bed condition

As measured from change in status from baseline

Time frame: Up to 24 weeks

Secondary Outcomes

Improvement in patient reported pain

As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)

Time frame: Up to 24 weeks

Improvement in patient reported quality of life

As measured by change in status from baseline as assessed by the SF-12 QoL.

Time frame: Up to 24 weeks

Data from ClinicalTrials.gov

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