Status:
COMPLETED
Impact of V.A.C. Veraflo Therapy in Wounds Requiring Debridement Within an Orthopedic Practice
Lead Sponsor:
LifeBridge Health
Collaborating Sponsors:
Kinetic Concepts, Inc.
Conditions:
Wounds and Injuries
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The objective to this study is to determine the effectiveness of V.A.C.Veraflo negative pressure wound therapy with instillation, when compared to historical controls of V.A.C Therapy without instilla...
Detailed Description
The V.A.C.Ulta™ Negative Pressure Wound Therapy System is a 510(k) -cleared, Class II device (K100657) with the following indication for use: "the V.A.C.Ulta™ Negative Pressure Wound Therapy System is...
Eligibility Criteria
Inclusion
- Signed Informed Consent.
- Patients requiring surgical debridement for wounds with exposed hardware and/or bone, traumatic wounds, dehisced wounds, post-surgical wounds, and pressure ulcers/sores requiring debridement.
- Age: 18 years and above.
- Gender: Male or Female.
- No use of Investigational Agents/Devices on study or within 30 days prior to enrollment.
- Subjects who will be locally available for the next 6 months.
Exclusion
- Wounds involving prosthetic joints.
- Patients who are unable to adhere to scheduled study visits.
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2017
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02266771
Start Date
September 1 2014
End Date
December 1 2017
Last Update
March 15 2018
Active Locations (1)
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1
Rubin Institute for Advanced Orthopedics, Sinai Hospital of Baltimore, LifeBridge Health
Baltimore, Maryland, United States, 21215