Subcutaneous Injection and Ultrasonic Dispersion of Cefazolin Into Chronic Pelvic-Region Pressure Ulcers in Persons With Spinal Cord Injury
Subcutaneous Injection and Ultrasonic Dispersion of Cefazolin Into Chronic Pelvic-Region Pressure Ulcers in Persons With Spinal Cord Injury
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.
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.