Clinical trial NCT03070925: Prospective PuraPly™ AM Case Series Study
Official title: A Prospective, Observational Study of the Use of PuraPly™ Antimicrobial (PuraPly AM) in the Management of Wounds
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pressure Ulcers
Venous Ulcers
Diabetic Ulcers
Surgical Wounds
Trauma Wounds
Keywords: Antimicrobial
Collagen
Bioburden
Biofilm
PHMB
Chronic wounds
Acute wounds
Lead sponsor: Organogenesis
Sponsor class: INDUSTRY
First posted: 2017-03-06
Enrollment: 43
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: 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 including the management of bioburden, support of granulation tissue formation, and support of wound closure.

Brief summary: The PuraPly AM case series is a prospective, observational study for patients who have received PuraPly AM which consists of a collagen sheet coated with polyhexamethylene biguanide 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.

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)
   * Trauma wounds (abrasions, lacerations, second-degree burns, skin tears)
   * 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 polyhexamethylene biguanide hydrochloride (PHMB)
4. Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products

Primary outcomes:
measure: Improvement in wound bed condition
timeFrame: 12 Weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lake Success
country: United States
facility: Northwell Health, Inc
state: New York
Study officials:
affiliation: Northwell Health, Inc.
name: Alisha Oropallo, MD
role: PRINCIPAL_INVESTIGATOR
References: