Trials / Completed
CompletedNCT03286452
The RESPOND Registry
Real-World Effectiveness Study of PuraPly™ AM on Wounds
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 310 (actual)
- Sponsor
- Organogenesis · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
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
- Draining Wounds
- Chronic Vascular Ulcer
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PuraPly™ Antimicrobial Wound Matrix | PuraPly™ Antimicrobial Wound Matrix consists of a collagen sheet coated with 0.1% polyhexamethylenebiguanide hydrochloride (PHMB) intended for the management of wounds. |
Timeline
- Start date
- 2017-02-21
- Primary completion
- 2018-07-15
- Completion
- 2019-01-26
- First posted
- 2017-09-18
- Last updated
- 2019-02-27
Locations
15 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03286452. Inclusion in this directory is not an endorsement.