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| Name | Class |
|---|---|
| Continuum Clinical Inc. | UNKNOWN |
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The RESPOND Registry is an observational study to assess the impact of PuraPlyâ„¢ AM on the management of wounds in real world clinical settings; no experimental intervention is involved.
The purpose of this study is to assess the impact of PuraPlyâ„¢ 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 PuraPlyâ„¢ 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 PuraPlyâ„¢ 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 PuraPlyâ„¢ AM.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PuraPlyâ„¢ Antimicrobial Wound Matrix | Device | PuraPlyâ„¢ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. |
|
| 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 |
| 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 |
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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 PuraPlyâ„¢ AM, including:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Advanced Wound Care Center at Yavapai Regional Medical Center | Prescott Valley | Arizona | 86314 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32476449 | Derived | 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. |
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As measured by change in status from baseline as assessed by the SF-12 QoL.
| Up to 24 weeks |
| 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. | Principal Investigator |
| Jupiter Medical Center |
| Jupiter |
| Florida |
| 33458 |
| United States |
| West Gables Rehab Hospital | Miami | Florida | 33155 | United States |
| Institute for Advanced Wound Healing; Northshore Specialty Hospital | Covington | Louisiana | 70433 | United States |
| Wound Care Associates, LLC. | Hammond | Louisiana | 70403 | United States |
| Opelousas General Hospital Wound Center | Opelousas | Louisiana | 70570 | United States |
| Saint Louis Foot and Ankle | St Louis | Missouri | 63128 | United States |
| CentraState Medical Center | Freehold | New Jersey | 07728 | United States |
| Robert Wood Johnson Hamilton | Hamilton | New Jersey | 08690 | United States |
| Southampton Hospital | Southampton | New York | 11968 | United States |
| Wayne Memorial Hospital | Goldsboro | North Carolina | 27534 | United States |
| Sacred Heart Hospital | Allentown | Pennsylvania | 18104 | United States |
| Harrisburg Foot and Ankle Center, Inc. | Harrisburg | Pennsylvania | 17112 | United States |
| Greensville Health System | Greenville | South Carolina | 29605 | United States |
| Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute | Madison | Wisconsin | 53713 | United States |
| ID | Term |
|---|---|
| D003668 | Pressure Ulcer |
| D014647 | Varicose Ulcer |
| D000072836 | Surgical Wound |
| ID | Term |
|---|---|
| D012883 | Skin Ulcer |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D014648 | Varicose Veins |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D007871 | Leg Ulcer |
| D014947 | Wounds and Injuries |
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