Pressure UlcersNCT03070925
Prospective PuraPly™ AM Case Series Study
An observational study of Pressure Ulcers and Venous Ulcers, run by Organogenesis at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers
- What is being tested?
- PuraPly™ Antimicrobial Wound Matrix
- Type of treatment
- Medical device
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2016to May 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Participant is at least 18 years of age
- Participant has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- Participant has at least 1 wound appropriate for receiving PuraPly AM, including
- Partial and full-thickness wounds
- Pressure ulcers
- Venous ulcers
Show all 12Show fewer
- 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
Who cannot join
- Participant has a known sensitivity to porcine materials
- Participant has a third-degree burn
- Participant has a known sensitivity to polyhexamethylene biguanide hydrochloride (PHMB)
- Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Observational Study of the Use of PuraPly™ Antimicrobial (PuraPly AM) in the Management of Wounds
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.
Read the 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.
- Conditions
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Surgical Wounds, Trauma Wounds
- Being tested
- PuraPly™ Antimicrobial Wound Matrix
- Keywords
- Antimicrobial, Collagen, Bioburden, Biofilm, PHMB, Chronic wounds, Acute wounds
- Medical subject headings
- Pressure Ulcer, Varicose Ulcer, Surgical Wound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PuraPly™ Antimicrobial Wound MatrixDevice
Also called PuraPly™ Antimicrobial, PuraPly™ AM
PuraPly AM consists of a collagen sheet coated with polyhexamethylene biguanide 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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in wound bed condition
As measured from change in status from baseline
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2017
- Study startNov 2016
- Primary completionApr 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alisha Oropallo, MD, Principal investigator, Northwell Health, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070925
- Sponsor's protocol ID
- 16-AW-002-PPAM
- Status last verified
- Aug 2017
- First submitted
- 2 Dec 2016
- Last updated
- 31 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Study of the Use of PuraPly™ Antimicrobial (PuraPly AM) in the Management of Wounds
- ClinicalTrials.gov ID
- NCT03070925
- Acronym / sponsor ID
- 16-AW-002-PPAM
- Conditions
- Pressure Ulcers, Venous Ulcers, Diabetic Ulcers, Surgical Wounds, Trauma Wounds
- Keywords
- Antimicrobial, Collagen, Bioburden, Biofilm, PHMB, Chronic wounds, Acute wounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Study start
- Nov 2016 (actual)
- Primary completion
- Apr 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 6 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- Participant is at least 18 years of age
- Participant has read, understood and signed and Institutional Review Board (IRB) approved Informed Consent Form (ICF).
- Participant has at least 1 wound appropriate for receiving PuraPly AM, including
Key exclusion criteria (4 listed)
- Participant has a known sensitivity to porcine materials
- Participant has a third-degree burn
- Participant has a known sensitivity to polyhexamethylene biguanide hydrochloride (PHMB)
- Participants receiving concurrent treatment with other topical antimicrobials or skin substitute products
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PuraPly™ Antimicrobial Wound MatrixAlso: PuraPly™ Antimicrobial, PuraPly™ AMPuraPly AM consists of a collagen sheet coated with polyhexamethylene biguanide 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. | Device | – |
Primary outcome
Improvement in wound bed condition
Time frame: 12 Weeks
As measured from change in status from baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2017.
- Individual participant dataSharing planned: Undecided
Related trials for Pressure Ulcers
RecruitingPhase 4
Clinical Trial Evaluating a Single Layer Amniotic Membrane and Standard of Care in the Management of Nonhealing Pressure Ulcers
Pressure Ulcer, Ulcer, Pressure
Not yet recruiting
Comparison of Negative Pressure Wound Therapy Versus Moist Wound Dressing in Diabetic Foot Ulcer Patients
Diabetic Foot Ulcer
Recruiting
Implementing a Decision Support Tool to Prevent Community-Acquired Pressure Injury in Spinal Cord Injury (SCI) in the Spinal Cord Injury Clinic
Spinal Cord Injury, Pressure Injury
Recruiting
Physical Therapy Wound Care Modalities in Patients With Spinal Cord Injury (SCI)
Spinal Cord Injuries, Pressure Injuries
Not yet recruitingObservational study
Explainable AI for Prospective Pressure Injury Staging
Pressure Injury
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alisha Oropallo, MD principal investigator
Northwell Health, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcers and Venous Ulcers, run by Organogenesis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in wound bed condition (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2017.