Partial Thickness WoundRESPONDNCT03286452
The RESPOND Registry
An observational study of Partial Thickness Wound and Pressure Ulcer, run by Organogenesis at 15 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Partial Thickness Wound, Pressure Ulcer, Venous Ulcer
- What is being tested?
- PuraPly™ Antimicrobial Wound Matrix
- Type of treatment
- Medical device
- How many people
- 310 participants
- Where
- 15 sitesUnited States
- Study dates
- 21 Feb 2017to 26 Jan 2019
- How long will I take part?
- 24 Weeks
- 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: 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.
Who may be able to join
- 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
Show all 12Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
United States15 sites
Sacred Heart Hospital
Allentown, Pennsylvania, 18104
Institute for Advanced Wound Healing; Northshore Specialty Hospital
Covington, Louisiana, 70433
CentraState Medical Center
Freehold, New Jersey, 07728
Wayne Memorial Hospital
Goldsboro, North Carolina, 27534
Greensville Health System
Greenville, South Carolina, 29605
Robert Wood Johnson Hamilton
Hamilton, New Jersey, 08690
Wound Care Associates, LLC.
Hammond, Louisiana, 70403
Harrisburg Foot and Ankle Center, Inc.
Harrisburg, Pennsylvania, 17112
Jupiter Medical Center
Jupiter, Florida, 33458
Meriter Hospital Inc., DBA: UnityPoint Health Heart and Vascular Institute
Madison, Wisconsin, 53713
West Gables Rehab Hospital
Miami, Florida, 33155
Opelousas General Hospital Wound Center
Opelousas, Louisiana, 70570
Advanced Wound Care Center at Yavapai Regional Medical Center
Prescott Valley, Arizona, 86314
Southampton Hospital
Southampton, New York, 11968
Saint Louis Foot and Ankle
St Louis, Missouri, 63128
About this study
Official title: Real-World Effectiveness Study of PuraPly™ AM on Wounds
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.
Read the detailed 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.
- Conditions
- Partial Thickness Wound, Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, 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™ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds.
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in size of wound area
As measured from change in size from baseline
Measured: Up to 24 weeks
Time to complete wound closure
As measured by time to complete wound closure from baseline
Measured: Up to 24 weeks
Improvement in wound bed condition
As measured from change in status from baseline
Measured: Up to 24 weeks
Secondary outcomes (2)
Improvement in patient reported pain
As measured change in status from baseline as assessed by the PAIN visual analogue scale (PAIN-VAS)
Measured: Up to 24 weeks
Improvement in patient reported quality of life
As measured by change in status from baseline as assessed by the SF-12 QoL.
Measured: Up to 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2017
- Study start21 Feb 2017
- Primary completion15 Jul 2018
- Study completion26 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Partial Thickness WoundStudies 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
- 310 participants (actual)
- Target duration
- 24 Weeks
Sponsor and investigators
- Lead sponsor
- Organogenesis
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Continuum Clinical Inc.
- Responsible party
- Sponsor
- Investigators
- Adam J Teichman, DPM, Principal investigator, PA Foot and Ankle AssociationShaun Carpenter, M.D., Principal investigator, Wound Care Associates, LLC.Daniel L Kapp, M.D., Principal investigator, Jupiter Medical CenterKerry Thibodeaux, M.D., Principal investigator, Opelousas General Hospital Wound CenterGeorge Koullias, M.D., Principal investigator, Southampton HospitalRaymond Abdo, DPM, Principal investigator, Saint Louis Foot and AnkleBarry Wisler, DPM, Principal investigator, Robert Wood Johnson HamiltonCarlos Trabanco, MD, Principal investigator, West Gables Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03286452
- Sponsor's protocol ID
- 16-REG-002-PPAM
- Acronym
- RESPOND
- Status last verified
- Feb 2019
- First submitted
- 26 Aug 2017
- Last updated
- 27 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
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.
PubMed 32476449
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real-World Effectiveness Study of PuraPly™ AM on Wounds
- ClinicalTrials.gov ID
- NCT03286452
- Acronym / sponsor ID
- RESPOND / 16-REG-002-PPAM
- Conditions
- Partial Thickness Wound, Pressure Ulcer, Venous Ulcer, Diabetic Ulcer, Surgical Wounds, Trauma Wounds
- Keywords
- Antimicrobial, Collagen, Bioburden, Biofilm, PHMB, Chronic wounds, Acute wounds
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 310 participants (actual)
- Lead sponsor
- OrganogenesisIndustry (pharma, biotech, devices)
- Collaborators
- Continuum Clinical Inc.
- Study start
- 21 Feb 2017 (actual)
- Primary completion
- 15 Jul 2018 (actual)
- Study completion
- 26 Jan 2019 (actual)
- First posted
- 18 Sep 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 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.
Detailed 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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 24 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (12 listed)
- 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:
Key exclusion criteria (4 listed)
- 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.
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™ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. | Device | – |
Primary outcome
Reduction in size of wound area
Time frame: Up to 24 weeks
As measured from change in size from baseline
Time to complete wound closure
Time frame: Up to 24 weeks
As measured by time to complete wound closure from baseline
Improvement in wound bed condition
Time frame: Up to 24 weeks
As measured from change in status from baseline
2 secondary outcomes
Improvement in patient reported pain
Time frame: Up to 24 weeks
Improvement in patient reported quality of life
Time frame: Up to 24 weeks
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 27 Feb 2019.
- Derived from this study: PubMed 32476449Bain 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.
- Individual participant dataSharing planned: Undecided
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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.
Adam J Teichman, DPM principal investigator
PA Foot and Ankle Association
Shaun Carpenter, M.D. principal investigator
Wound Care Associates, LLC.
Daniel L Kapp, M.D. principal investigator
Jupiter Medical Center
15 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Partial Thickness Wound and Pressure Ulcer, run by Organogenesis at 15 sites 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 27 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites 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?
Reduction in size of wound area (time frame: Up to 24 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03286452, which also lists 1 linked publication.
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 27 Feb 2019; AzTrials last refreshed its copy on 27 Oct 2026.