The RESPOND Registry

Organogenesis

Status: Completed

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

Treatments: Device: PuraPly™ Antimicrobial Wound Matrix

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03286452

16-REG-002-PPAM

Details and patient eligibility

About

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.

Full 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.

Enrollment: 310 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.