NCT03286452

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
310

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2017

Geographic Reach
1 country

15 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 21, 2017

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 26, 2017

Completed
23 days until next milestone

First Posted

Study publicly available on registry

September 18, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2018

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 26, 2019

Completed
Last Updated

February 27, 2019

Status Verified

February 1, 2019

Enrollment Period

1.4 years

First QC Date

August 26, 2017

Last Update Submit

February 26, 2019

Conditions

Partial Thickness WoundPressure UlcerVenous UlcerDiabetic UlcerSurgical WoundsTrauma WoundsDraining WoundsChronic Vascular Ulcer

Keywords

AntimicrobialCollagenBioburdenBiofilmPHMBChronic woundsAcute wounds

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (2)

  • Improvement in patient reported pain

    Up to 24 weeks

  • Improvement in patient reported quality of life

    Up to 24 weeks

Interventions

PuraPly™ Antimicrobial Wound MatrixDEVICE

PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds.

Also known as: PuraPly™ Antimicrobial, PuraPly™ AM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Advanced Wound Care Center at Yavapai Regional Medical Center

Prescott Valley, Arizona, 86314, United States

Location

Jupiter Medical Center

Jupiter, Florida, 33458, United States

Location

West Gables Rehab Hospital

Miami, Florida, 33155, United States

Location

Institute for Advanced Wound Healing; Northshore Specialty Hospital

Covington, Louisiana, 70433, United States

Location

Wound Care Associates, LLC.

Hammond, Louisiana, 70403, United States

Location

Opelousas General Hospital Wound Center

Opelousas, Louisiana, 70570, United States

Location

Saint Louis Foot and Ankle

St Louis, Missouri, 63128, United States

Location

CentraState Medical Center

Freehold, New Jersey, 07728, United States

Location

Robert Wood Johnson Hamilton

Hamilton, New Jersey, 08690, United States

Location

Southampton Hospital

Southampton, New York, 11968, United States

Location

Wayne Memorial Hospital

Goldsboro, North Carolina, 27534, United States

Location

Sacred Heart Hospital

Allentown, Pennsylvania, 18104, United States

Location

Harrisburg Foot and Ankle Center, Inc.

Harrisburg, Pennsylvania, 17112, United States

Location

Greensville Health System

Greenville, South Carolina, 29605, United States

Location

Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute

Madison, Wisconsin, 53713, United States

Location

Related Publications (1)

  • 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.

    PMID: 32476449DERIVED

MeSH Terms

Conditions

Pressure UlcerVaricose UlcerSurgical Wound

Condition Hierarchy (Ancestors)

Skin UlcerSkin DiseasesSkin and Connective Tissue DiseasesVaricose VeinsVascular DiseasesCardiovascular DiseasesLeg UlcerWounds and Injuries

Study Officials

  • 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.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
24 Weeks
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 26, 2017

First Posted

September 18, 2017

Study Start

February 21, 2017

Primary Completion

July 15, 2018

Study Completion

January 26, 2019

Last Updated

February 27, 2019

Record last verified: 2019-02

Locations

US(15)