The RESPOND Registry

Pressure Ulcer Clinical Trial

— RESPOND  

Official title:

Real-World Effectiveness Study of PuraPly™ AM on Wounds

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03286452
• Other study ID #: 16-REG-002-PPAM
• Status: Completed
• Start date: February 21, 2017
• Est. completion date: January 26, 2019

Study information

• Verified date: February 2019
• Source: Organogenesis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 310
• Est. completion date: January 26, 2019
• Est. primary completion date: July 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Vascular Ulcer
• Diabetic Ulcer
• Draining Wounds
• Partial Thickness Wound
• Pressure Ulcer
• Surgical Wound
• Surgical Wounds
• Trauma Wounds
• Ulcer
• Varicose Ulcer
• Venous Ulcer
• Wounds and Injuries

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.

Locations

Country	Name	City	State
United States	Sacred Heart Hospital	Allentown	Pennsylvania
United States	Institute for Advanced Wound Healing; Northshore Specialty Hospital	Covington	Louisiana
United States	CentraState Medical Center	Freehold	New Jersey
United States	Wayne Memorial Hospital	Goldsboro	North Carolina
United States	Greensville Health System	Greenville	South Carolina
United States	Robert Wood Johnson Hamilton	Hamilton	New Jersey
United States	Wound Care Associates, LLC.	Hammond	Louisiana
United States	Harrisburg Foot and Ankle Center, Inc.	Harrisburg	Pennsylvania
United States	Jupiter Medical Center	Jupiter	Florida
United States	Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute	Madison	Wisconsin
United States	West Gables Rehab Hospital	Miami	Florida
United States	Opelousas General Hospital Wound Center	Opelousas	Louisiana
United States	Advanced Wound Care Center at Yavapai Regional Medical Center	Prescott Valley	Arizona
United States	Saint Louis Foot and Ankle	Saint Louis	Missouri
United States	Southampton Hospital	Southampton	New York

Sponsors (2)

Lead Sponsor	Collaborator
Organogenesis	Continuum Clinical Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction in size of wound area	As measured from change in size from baseline	Up to 24 weeks
Primary	Time to complete wound closure	As measured by time to complete wound closure from baseline	Up to 24 weeks
Primary	Improvement in wound bed condition	As measured from change in status from baseline	Up to 24 weeks
Secondary	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
Secondary	Improvement in patient reported quality of life	As measured by change in status from baseline as assessed by the SF-12 QoL.	Up to 24 weeks