The RESPOND Registry

Completed

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

• Registration Number: NCT03286452
• Lead Sponsor: Organogenesis

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.

Study Timeline

• Study Start: 2017-02-21
• Study First Submitted: 2017-08-26
• Study First Submitted QC: 2017-09-15
• Study First Posted: 2017-09-18
• Primary Completion: 2018-07-15
• Study Completion: 2019-01-26
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-26
• Last Update Posted: 2019-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 310

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Improvement in wound bed condition	Up to 24 weeks	As measured from change in status from baseline
Reduction in size of wound area	Up to 24 weeks	As measured from change in size from baseline
Time to complete wound closure	Up to 24 weeks	As measured by time to complete wound closure from baseline

Secondary Outcome Measures

Name	Time	Method
Improvement in patient reported pain	Up to 24 weeks	As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)
Improvement in patient reported quality of life	Up to 24 weeks	As measured by change in status from baseline as assessed by the SF-12 QoL.

Trial Locations

Locations (15)

Jupiter Medical Center; 🇺🇸 Jupiter, Florida, United States

West Gables Rehab Hospital; 🇺🇸 Miami, Florida, United States

Saint Louis Foot and Ankle; 🇺🇸 Saint Louis, Missouri, United States

Southampton Hospital; 🇺🇸 Southampton, New York, United States

Greensville Health System; 🇺🇸 Greenville, South Carolina, United States

Sacred Heart Hospital; 🇺🇸 Allentown, Pennsylvania, United States

Wayne Memorial Hospital; 🇺🇸 Goldsboro, North Carolina, United States

Harrisburg Foot and Ankle Center, Inc.; 🇺🇸 Harrisburg, Pennsylvania, United States

Opelousas General Hospital Wound Center; 🇺🇸 Opelousas, Louisiana, United States

CentraState Medical Center; 🇺🇸 Freehold, New Jersey, United States

Wound Care Associates, LLC.; 🇺🇸 Hammond, Louisiana, United States

Advanced Wound Care Center at Yavapai Regional Medical Center; 🇺🇸 Prescott Valley, Arizona, United States

Institute for Advanced Wound Healing; Northshore Specialty Hospital; 🇺🇸 Covington, Louisiana, United States

Robert Wood Johnson Hamilton; 🇺🇸 Hamilton, New Jersey, United States

Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute; 🇺🇸 Madison, Wisconsin, United States