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PuraPly™ Antimicrobial Wound Matrix and Wound Management (PuraPlyAM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03070938
Recruitment Status : Completed
First Posted : March 6, 2017
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
Organogenesis

Tracking Information
First Submitted Date December 7, 2016
First Posted Date March 6, 2017
Last Update Posted Date November 6, 2017
Actual Study Start Date November 2016
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: March 3, 2017)
Improvement in wound bed condition [ Time Frame: 12 Weeks ]
As measured from change in status from baseline
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03070938 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title PuraPly™ Antimicrobial Wound Matrix and Wound Management
Official Title A Prospective, Observational Study of the Use of PuraPly™ Antimicrobial in the Management of Wounds
Brief Summary The PuraPly Antimicrobial Wound Matrix (PuraPly AM) case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylenbiguanide hydrochloride (PHMB) and is intended for the management of wounds; no experimental intervention is involved.
Detailed Description

The purpose of the case series is to assess the ability of PuraPly AM to meet wound specific treatment goals including management of bioburden, support of granulation tissue formation and support of wound closure. Patients will undergo clinical assessments and receive the standard of care as determined by the treating physician.

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 12 weeks following application of PuraPly AM.

Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Eligible patients are men and women at least 18 years old, with an eligible target wound that meets the Investigator's wound specific treatment goals that include the management of bioburden, support of granulation tissue formation and support of wound closure.
Condition
  • Pressure Ulcer
  • Venous Ulcer
  • Diabetic Ulcer
  • Surgical Wound
  • Trauma Wound
Intervention Device: PuraPly™ Antimicrobial Wound Matrix
PuraPly AM consists of a collagen sheet coated with polyhexamethylenbiguanide hydrochloride (PHMB) intended for the management of wounds. PuraPly AM is supplied dry in sheet form. The device is packaged in sterile, sealed single patches.
Other Name: PuraPly AM
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 3, 2017)
100
Original Estimated Enrollment Same as current
Actual Study Completion Date October 2017
Actual Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Participant is at least 18 years of age
  2. Participant has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).
  3. Participant has at least 1 wound appropriate for receiving PuraPly AM, including

    • Partial and full-thickness wounds
    • Pressure ulcers
    • Venous ulcers
    • Diabetic ulcers
    • Chronic vascular ulcers
    • Tunneled/undermined wounds
    • Surgical wounds (donor sites/grafts, post-Mohs' surgery, post-laser surgery, podiatric, wound dehiscence) h. Trauma wounds (abrasions, lacerations, second-degree burns, skin tears) i. Draining wounds

Exclusion Criteria:

  1. Participant has a known sensitivity to porcine materials
  2. Participant has a third-degree burn
  3. Participant has a known sensitivity to polyhexamethylenbiguanide hydrochloride (PHMB)
  4. Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03070938
Other Study ID Numbers PuraPly AM Case Series
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Organogenesis
Study Sponsor Organogenesis
Collaborators Not Provided
Investigators
Principal Investigator: Scott Gorenstein, MD Winthrop University Hospital/ Winthrop Wound Healing Center
PRS Account Organogenesis
Verification Date October 2017