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The RESPOND Registry (RESPOND)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03286452
Recruitment Status : Completed
First Posted : September 18, 2017
Last Update Posted : February 27, 2019
Sponsor:
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
Change History
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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