The RESPOND Registry (RESPOND)

Real-World Effectiveness Study of PuraPly™ AM on Wounds

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.

Study Overview

• Status: Completed
• Conditions: Surgical Wounds; Pressure Ulcer; Venous Ulcer; Partial Thickness Wound; Diabetic Ulcer; Trauma Wounds; Draining Wounds; Chronic Vascular Ulcer
• Intervention / Treatment: Device: PuraPly™ Antimicrobial Wound Matrix

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
• Enrollment (Actual): 310

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Prescott Valley, Arizona, United States, 86314
      • Advanced Wound Care Center at Yavapai Regional Medical Center
  • Florida
    • Jupiter, Florida, United States, 33458
      • Jupiter Medical Center
    • Miami, Florida, United States, 33155
      • West Gables Rehab Hospital
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Institute for Advanced Wound Healing; Northshore Specialty Hospital
    • Hammond, Louisiana, United States, 70403
      • Wound Care Associates, LLC.
    • Opelousas, Louisiana, United States, 70570
      • Opelousas General Hospital Wound Center
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Saint Louis Foot and Ankle
  • New Jersey
    • Freehold, New Jersey, United States, 07728
      • CentraState Medical Center
    • Hamilton, New Jersey, United States, 08690
      • Robert Wood Johnson Hamilton
  • New York
    • Southampton, New York, United States, 11968
      • Southampton Hospital
  • North Carolina
    • Goldsboro, North Carolina, United States, 27534
      • Wayne Memorial Hospital
  • Pennsylvania
    • Allentown, Pennsylvania, United States, 18104
      • Sacred Heart Hospital
    • Harrisburg, Pennsylvania, United States, 17112
      • Harrisburg Foot and Ankle Center, Inc.
  • South Carolina
    • Greenville, South Carolina, United States, 29605
      • Greensville Health System
  • Wisconsin
    • Madison, Wisconsin, United States, 53713
      • Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in patient reported pain	As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)	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.	Up to 24 weeks

Collaborators and Investigators

• 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.

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): February 21, 2017
• Primary Completion (Actual): July 15, 2018
• Study Completion (Actual): January 26, 2019

Study Registration Dates

• First Submitted: August 26, 2017
• First Submitted That Met QC Criteria: September 15, 2017
• First Posted (Actual): September 18, 2017

Study Record Updates

• Last Update Posted (Actual): February 27, 2019
• Last Update Submitted That Met QC Criteria: February 26, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Keywords: Biofilm; PHMB; Collagen; Chronic wounds; Antimicrobial; Bioburden; Acute wounds
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Skin Diseases; Leg Ulcer; Skin Ulcer; Varicose Veins; Ulcer; Wounds and Injuries; Surgical Wound; Varicose Ulcer; Pressure Ulcer; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: 16-REG-002-PPAM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• 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