Subcutaneous Injection and Ultrasonic Dispersion of Cefazolin Into Chronic Pelvic-Region Pressure Ulcers in Persons With Spinal Cord Injury
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|ClinicalTrials.gov Identifier: NCT02584426|
Recruitment Status : Unknown
Verified February 2017 by William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center.
Recruitment status was: Recruiting
First Posted : October 22, 2015
Last Update Posted : March 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injury Chronic Pressure Ulcers||Device: Ultrasonic Distribution of Cefazolin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||20 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Actual Study Start Date :||January 2017|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
Experimental: Cefazolin Treatment
Subjects will receive antibiotic treatment with phonophoresis (i.e., hypodermoclysis) during test 1, and will be given standard of care for 8 weeks.
Device: Ultrasonic Distribution of Cefazolin
No Intervention: Standard of Care Control
Subjects will not receive intervention and will receive standard of care for 8 weeks.
- Percent Change in Surface area of a Chronic Pelvic Pressure Ulcer (PU) at 4 Weeks [ Time Frame: 4 weeks ]1. To determine the percent change in surface area of a chronic pelvic region pressure ulcer (PU) 4 weeks after hypodermoclysis with antibiotic treatment and ultrasonic dispersion compared to standard of care.
- Percent Change in Surface area of a Chronic Pelvic Pressure Ulcer (PU) at 8 Weeks [ Time Frame: 8 weeks ]2. To determine the percent change in surface area of a chronic pelvic region PU 8 weeks after hypodermoclysis with antibiotic treatment and ultrasonic dispersion compared to standard of care.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02584426
|Contact: William A Bauman, MD||(718) 584-9000 ext email@example.com|
|Contact: Joshua C Hobson, MS||(718) 584-9000 ext firstname.lastname@example.org|
|United States, New York|
|James J. Peters VA Medical Center||Recruiting|
|Bronx, New York, United States, 10468|
|Contact: Joshua C Hobson, M.S. 718-584-9000 ext 3129 email@example.com|