Clinical trial NCT03286452: The RESPOND Registry
Official title: Real-World Effectiveness Study of PuraPly™ AM on Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Partial Thickness Wound
Pressure Ulcer
Venous Ulcer
Diabetic Ulcer
Surgical Wounds
Trauma Wounds
Draining Wounds
Chronic Vascular Ulcer
Keywords: Antimicrobial
Collagen
Bioburden
Biofilm
PHMB
Chronic wounds
Acute wounds
Lead sponsor: Organogenesis
Sponsor class: INDUSTRY
Collaborators: name: Continuum Clinical Inc.
First posted: 2017-09-18
Enrollment: 310
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Reduction in size of wound area
timeFrame: Up to 24 weeks
measure: Time to complete wound closure
timeFrame: Up to 24 weeks
measure: Improvement in wound bed condition
timeFrame: Up to 24 weeks
Secondary outcomes:
measure: Improvement in patient reported pain
timeFrame: Up to 24 weeks
measure: Improvement in patient reported quality of life
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Prescott Valley
country: United States
facility: Advanced Wound Care Center at Yavapai Regional Medical Center
state: Arizona
city: Jupiter
country: United States
facility: Jupiter Medical Center
state: Florida
city: Miami
country: United States
facility: West Gables Rehab Hospital
state: Florida
city: Covington
country: United States
facility: Institute for Advanced Wound Healing; Northshore Specialty Hospital
state: Louisiana
city: Hammond
country: United States
facility: Wound Care Associates, LLC.
state: Louisiana
city: Opelousas
country: United States
facility: Opelousas General Hospital Wound Center
state: Louisiana
city: Saint Louis
country: United States
facility: Saint Louis Foot and Ankle
state: Missouri
city: Freehold
country: United States
facility: CentraState Medical Center
state: New Jersey
city: Hamilton
country: United States
facility: Robert Wood Johnson Hamilton
state: New Jersey
city: Southampton
country: United States
facility: Southampton Hospital
state: New York
city: Goldsboro
country: United States
facility: Wayne Memorial Hospital
state: North Carolina
city: Allentown
country: United States
facility: Sacred Heart Hospital
state: Pennsylvania
city: Harrisburg
country: United States
facility: Harrisburg Foot and Ankle Center, Inc.
state: Pennsylvania
city: Greenville
country: United States
facility: Greensville Health System
state: South Carolina
city: Madison
country: United States
facility: Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute
state: Wisconsin
Study officials:
affiliation: PA Foot and Ankle Association
name: Adam J Teichman, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Wound Care Associates, LLC.
name: Shaun Carpenter, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Jupiter Medical Center
name: Daniel L Kapp, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Opelousas General Hospital Wound Center
name: Kerry Thibodeaux, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Southampton Hospital
name: George Koullias, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Louis Foot and Ankle
name: Raymond Abdo, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: Robert Wood Johnson Hamilton
name: Barry Wisler, DPM
role: PRINCIPAL_INVESTIGATOR
affiliation: West Gables Rehabilitation Hospital
name: Carlos Trabanco, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute
name: Ifat Kamin, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institute for Advanced Wound Healing; Northshore Specialty Hospital
name: Amanda Estapa, NP
role: PRINCIPAL_INVESTIGATOR
affiliation: CentraState Medical Center
name: Michael Menack, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Advanced Wound Care Center at Yavapai Regional Medical Center
name: Ritu Gothwal, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Tufts Medical Center
name: Mark Iafrati, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Saint Joseph's Center for Wound Care and Hyperbaric Medicine
name: Paula Pons, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma Wound Center
name: Taysha Howell, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harrisburg Foot and Ankle Center, Inc.
name: Allan Grossman, DPM
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.