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The RESPOND Registry (RESPOND)

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ClinicalTrials.gov Identifier: NCT03286452
Recruitment Status : Active, not recruiting
First Posted : September 18, 2017
Last Update Posted : September 18, 2018
Sponsor:
Collaborator:
Continuum Clinical Inc.
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Partial Thickness Wound Pressure Ulcer Venous Ulcer Diabetic Ulcer Surgical Wounds Trauma Wounds Draining Wounds Chronic Vascular Ulcer 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 [Patient Registry]
Actual Enrollment : 310 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 24 Weeks
Official Title: Real-World Effectiveness Study of PuraPly™ AM on Wounds
Actual Study Start Date : February 21, 2017
Actual Primary Completion Date : July 15, 2018
Estimated Study Completion Date : February 15, 2019

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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


Primary Outcome Measures :
  1. Reduction in size of wound area [ Time Frame: Up to 24 weeks ]
    As measured from change in size from baseline

  2. Time to complete wound closure [ Time Frame: Up to 24 weeks ]
    As measured by time to complete wound closure from baseline

  3. Improvement in wound bed condition [ Time Frame: Up to 24 weeks ]
    As measured from change in status from baseline


Secondary Outcome Measures :
  1. 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)

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03286452


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

Responsible Party: Organogenesis
ClinicalTrials.gov Identifier: NCT03286452     History of Changes
Other Study ID Numbers: 16-REG-002-PPAM
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: September 18, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Organogenesis:
Antimicrobial
Collagen
Bioburden
Biofilm
PHMB
Chronic wounds
Acute wounds

Additional relevant MeSH terms:
Wounds and Injuries
Ulcer
Pressure Ulcer
Surgical Wound
Varicose Ulcer
Pathologic Processes
Skin Ulcer
Skin Diseases
Varicose Veins
Vascular Diseases
Cardiovascular Diseases
Leg Ulcer
Anti-Infective Agents
Anti-Bacterial Agents