The RESPOND Registry

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

Official Title
-----------------
Real-World Effectiveness Study of PuraPly™ AM on Wounds

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

Intervention / Treatment
-----------------
* Device: PuraPly™ Antimicrobial Wound Matrix


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PuraPly™ Antimicrobial Wound Matrix|PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in size of wound area | As measured from change in size from baseline | Up to 24 weeks | 
| Time to complete wound closure | As measured by time to complete wound closure from baseline | Up to 24 weeks | 
| Improvement in wound bed condition | As measured from change in status from baseline | Up to 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in patient reported pain | As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS) | 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. | Up to 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antimicrobial, Collagen, Bioburden, Biofilm, PHMB, Chronic wounds, Acute wounds