The RESPOND Registry (RESPOND)

• ClinicalTrials.gov Identifier: NCT03286452
• Recruitment Status: Completed
• First Posted: September 18, 2017
• Last Update Posted: February 27, 2019
• Sponsor: Organogenesis
• Collaborator: Continuum Clinical Inc.
• Information provided by (Responsible Party): Organogenesis

Tracking Information

• First Submitted Date: August 26, 2017
• First Posted Date: September 18, 2017
• Last Update Posted Date: February 27, 2019
• Actual Study Start Date: February 21, 2017
• Actual Primary Completion Date: July 15, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 15, 2017)

• Reduction in size of wound area [ Time Frame: Up to 24 weeks ]
  As measured from change in size from baseline
• Time to complete wound closure [ Time Frame: Up to 24 weeks ]
  As measured by time to complete wound closure from baseline
• Improvement in wound bed condition [ Time Frame: Up to 24 weeks ]
  As measured from change in status from baseline

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 15, 2017)

• Improvement in patient reported pain [ Time Frame: 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 [ Time Frame: Up to 24 weeks ]
  As measured by change in status from baseline as assessed by the SF-12 QoL.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: The RESPOND Registry
• Official Title: Real-World Effectiveness Study of PuraPly™ AM on Wounds
• 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 Type: Observational [Patient Registry]
• Study Design: Observational Model: Case-Only; Time Perspective: Prospective
• Target Follow-Up Duration: 24 Weeks
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: 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.

Condition

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

Intervention

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.

Other Names:

• PuraPly™ Antimicrobial
• PuraPly™ AM

• Study Groups/Cohorts: Not Provided
• Publications *: Bain MA, Koullias GJ, Morse K, Wendling S, Sabolinski ML. Type I collagen matrix plus polyhexamethylene biguanide antimicrobial for the treatment of cutaneous wounds. J Comp Eff Res. 2020 Jul;9(10):691-703. doi: 10.2217/cer-2020-0058. Epub 2020 Jun 1.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 17, 2018): 310
• Original Estimated Enrollment (submitted: September 15, 2017): 300
• Actual Study Completion Date: January 26, 2019
• Actual Primary Completion Date: July 15, 2018 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03286452
• Other Study ID Numbers: 16-REG-002-PPAM
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Organogenesis
• Study Sponsor: Organogenesis
• Collaborators: Continuum Clinical Inc.

Investigators

• Principal Investigator: Adam J Teichman, DPM; PA Foot and Ankle Association
• Principal Investigator: Shaun Carpenter, M.D.; Wound Care Associates, LLC.
• Principal Investigator: Daniel L Kapp, M.D.; Jupiter Medical Center
• Principal Investigator: Kerry Thibodeaux, M.D.; Opelousas General Hospital Wound Center
• Principal Investigator: George Koullias, M.D.; Southampton Hospital
• Principal Investigator: Raymond Abdo, DPM; Saint Louis Foot and Ankle
• Principal Investigator: Barry Wisler, DPM; Robert Wood Johnson Hamilton
• Principal Investigator: Carlos Trabanco, MD; West Gables Rehabilitation Hospital
• Principal Investigator: Ifat Kamin, MD; Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute
• Principal Investigator: Amanda Estapa, NP; Institute for Advanced Wound Healing; Northshore Specialty Hospital
• Principal Investigator: Michael Menack, MD; CentraState Medical Center
• Principal Investigator: Ritu Gothwal, MD; Advanced Wound Care Center at Yavapai Regional Medical Center
• Principal Investigator: Mark Iafrati, MD; Tufts Medical Center
• Principal Investigator: Paula Pons, MD; Saint Joseph's Center for Wound Care and Hyperbaric Medicine
• Principal Investigator: Taysha Howell, MD; Oklahoma Wound Center
• Principal Investigator: Allan Grossman, DPM; Harrisburg Foot and Ankle Center, Inc.

• PRS Account: Organogenesis
• Verification Date: February 2019