The RESPOND Registry (NCT03286452) | Clinical Trial Compass
CompletedNot Applicable
The RESPOND Registry
United States310 participantsStarted 2017-02-21
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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.