An observational study in Partial Thickness Wound, Pressure Ulcer and Venous Ulcer, sponsored by Organogenesis. Completed at 15 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-02-27.
Sponsored by Organogenesis · Observational
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.
Approximately 300 patients to be enrolled by approximately 30 US-based Physician Investigators. Patients are male or female at least 18 years old, with an eligible target wound that meets the Investigator's wound specific treatment goals; including the management of bioburden, support of granulation tissue formation, and support of wound closure.
Patient has a wound appropriate for receiving PuraPly™ AM, including:
Exclusion Criteria:
PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds.
Also known as: PuraPly™ Antimicrobial, PuraPly™ AM
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
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
Plan to share: Undecided
This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.
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Organogenesis