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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
Sponsor:
Information provided by (Responsible Party):
William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center

Brief Summary:
Pressure ulcers (PU) are skin breakdowns that often form after blood flow in the skin is reduced from prolonged and repeated exposure to externally applied forces. As many as 85% of individuals with a spinal cord injury (SCI) report the occurrence of at least 1 PU since being injured. Despite the increasing attention and emphasis on prevention, PUs still represent a major health risk for persons with SCI. PUs and other skin breakdowns are at risk for becoming infected; it is not uncommon for many different types of "bugs" to be found in the wound. It has been assumed that the presence of these organisms did not impede wound healing or skin graft survival. The current proposal will use a new type of procedure that involves the direct injection of an antibiotic (in saline) into the skin beneath the wound; it is then distributed throughout the wound using a second device that uses sound waves. The study will determine if the antibiotic treatment and the standard of care improves the rate wound closure compared to the standard of care alone in persons with SCI and a chronic pelvic-region PU.

Condition or disease Intervention/treatment Phase
Spinal Cord Injury Chronic Pressure Ulcers Device: Ultrasonic Distribution of Cefazolin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years to 79 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female, age 18 to 79;
  2. Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of neurological lesion);
  3. American Spinal Injury Association Impairment Scale (AIS) designation of A or B with no sensation in the pelvic region;
  4. At least one Stage III or IV PU in the pelvic region (e.g., ischial or trochanteric regions) that has not shown signs of healing for a period of at least 1 month; and,
  5. Hemoglobin A1C ≤7.0%.

Exclusion Criteria:

  1. Persons who are candidates for or elect to have reconstructive flap surgery of the PU;
  2. Unresolved osteomyelitis diagnosed by clinical impression and supported by one or more of the following: 1) history and examination of the pressure ulcer (i.e., visible bone), 2) bone contact on sterile probe, 3) bone that has lost its normal consistency, 4) magnetic resonance imaging, or 5) open bone biopsy;
  3. Hemoglobin A1C >7.0%;
  4. Psychopathology (documentation in the medical record or history of self-abusive behavior specific to PU healing which may or may not include major or minor psychiatric illness (that may conflict with the study objectives;
  5. Acute illness or systemic infection;
  6. Allergy to cefazolin;
  7. Allergy to penicillin;
  8. History of clinically significant or uncontrolled cardiac disease, including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association functional classification of 3;
  9. Previously diagnosed active malignant disease;
  10. Suspicion of skin cancer at the PU site (i.e., clinical evaluation is currently on-going);
  11. Life expectancy less than 12 months;
  12. Nephrosis, hemodialysis or chronic ambulatory peritoneal dialysis therapy;
  13. Moderate to high dose glucocorticoid administrations (i.e., ≥ 40 mg prednisone or equivalent steroid dose) within the past 3 months;
  14. Diminished mental capacity;
  15. Inability or unwillingness of subject to provide informed consent; or,
  16. Pregnancy or women who may become pregnant during the course of the study, or those who are nursing.

Information from the National Library of Medicine

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


Contacts
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Contact: William A Bauman, MD (718) 584-9000 ext 5428 william.bauman@va.gov
Contact: Joshua C Hobson, MS (718) 584-9000 ext 3129 joshua.hobson@va.gov

Locations
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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    joshua.hobson@va.gov   
Sponsors and Collaborators
James J. Peters Veterans Affairs Medical Center

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Responsible Party: William A. Bauman, M.D., Research Center Director, James J. Peters Veterans Affairs Medical Center
ClinicalTrials.gov Identifier: NCT02584426     History of Changes
Other Study ID Numbers: BAU-15-043
First Posted: October 22, 2015    Key Record Dates
Last Update Posted: March 3, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center:
Cefazolin
Additional relevant MeSH terms:
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Spinal Cord Injuries
Pressure Ulcer
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Skin Ulcer
Skin Diseases
Cefazolin
Anti-Bacterial Agents
Anti-Infective Agents