VeraFlo With Prontosan® and Wound and Fracture Healing.
NCT02621073 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7
Last updated 2019-06-20
Summary
To answer the question: "Do Prontosan instillations decrease time to wound and fracture healing and decrease bacterial load compared to wound vac treatment without Prontosan?," we will enroll up to 30 subjects (for an anticipated 20 complete data sets) into this trial. The subjects will be split equally into two different groups by randomization. One groups will have wound vac therapy with Prontosan, and one group will have wound vac therapy without Prontosan. Data related to wound and fracture healing and bacterial load will be assessed between the two groups to determine if wound vac therapy with Prontosan speeds up healing time and decreases bacterial load.
Conditions
Interventions
- DRUG
-
VeraFlo with Prontosan
VeraFlo device with Prontosan instillation (n=10).
- DEVICE
-
V.A.C Ulta System
V.A.C. Ulta Negative Pressure Wound Therapy System without instillation (n=10).
Sponsors & Collaborators
-
Brett Crist
lead OTHER
Principal Investigators
-
Brett D Crist, MD · University of Missouri, Missouri Orthopaedic Institute
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2015-11-30
- Primary Completion
- 2017-12-31
- Completion
- 2017-12-31
Countries
- United States
Study Locations
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