Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
310 participants
OBSERVATIONAL
2017-02-21
2019-01-26
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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 third-degree burn.
* Patient has a known sensitivity to polyhexamethylenebiguanide hydrochloride (PHMB).
* Patient's target wound was previously treated with PuraPly™ AM.
18 Years
ALL
No
Sponsors
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Continuum Clinical Inc.
UNKNOWN
Organogenesis
INDUSTRY
Responsible Party
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Principal Investigators
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Adam J Teichman, DPM
Role: PRINCIPAL_INVESTIGATOR
PA Foot and Ankle Association
Shaun Carpenter, M.D.
Role: PRINCIPAL_INVESTIGATOR
Wound Care Associates, LLC.
Daniel L Kapp, M.D.
Role: PRINCIPAL_INVESTIGATOR
Jupiter Medical Center
Kerry Thibodeaux, M.D.
Role: PRINCIPAL_INVESTIGATOR
Opelousas General Hospital Wound Center
George Koullias, M.D.
Role: PRINCIPAL_INVESTIGATOR
Southampton Hospital
Raymond Abdo, DPM
Role: PRINCIPAL_INVESTIGATOR
Saint Louis Foot and Ankle
Barry Wisler, DPM
Role: PRINCIPAL_INVESTIGATOR
Robert Wood Johnson Hamilton
Carlos Trabanco, MD
Role: PRINCIPAL_INVESTIGATOR
West Gables Rehabilitation Hospital
Ifat Kamin, MD
Role: PRINCIPAL_INVESTIGATOR
Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute
Amanda Estapa, NP
Role: PRINCIPAL_INVESTIGATOR
Institute for Advanced Wound Healing; Northshore Specialty Hospital
Michael Menack, MD
Role: PRINCIPAL_INVESTIGATOR
CentraState Medical Center
Ritu Gothwal, MD
Role: PRINCIPAL_INVESTIGATOR
Advanced Wound Care Center at Yavapai Regional Medical Center
Mark Iafrati, MD
Role: PRINCIPAL_INVESTIGATOR
Tufts Medical Center
Paula Pons, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Joseph's Center for Wound Care and Hyperbaric Medicine
Taysha Howell, MD
Role: PRINCIPAL_INVESTIGATOR
Oklahoma Wound Center
Allan Grossman, DPM
Role: PRINCIPAL_INVESTIGATOR
Harrisburg Foot and Ankle Center, Inc.
Locations
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Advanced Wound Care Center at Yavapai Regional Medical Center
Prescott Valley, Arizona, United States
Jupiter Medical Center
Jupiter, Florida, United States
West Gables Rehab Hospital
Miami, Florida, United States
Institute for Advanced Wound Healing; Northshore Specialty Hospital
Covington, Louisiana, United States
Wound Care Associates, LLC.
Hammond, Louisiana, United States
Opelousas General Hospital Wound Center
Opelousas, Louisiana, United States
Saint Louis Foot and Ankle
St Louis, Missouri, United States
CentraState Medical Center
Freehold, New Jersey, United States
Robert Wood Johnson Hamilton
Hamilton, New Jersey, United States
Southampton Hospital
Southampton, New York, United States
Wayne Memorial Hospital
Goldsboro, North Carolina, United States
Sacred Heart Hospital
Allentown, Pennsylvania, United States
Harrisburg Foot and Ankle Center, Inc.
Harrisburg, Pennsylvania, United States
Greensville Health System
Greenville, South Carolina, United States
Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute
Madison, Wisconsin, United States
Countries
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References
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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.
Other Identifiers
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16-REG-002-PPAM
Identifier Type: -
Identifier Source: org_study_id
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