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

NCT02584426 | Completed

• 1 other identifier: BAU-15-043
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injury; Chronic Pressure Ulcers

Keywords

Cefazolin

Outcome Measures

Primary Outcomes (1)

• Percent Change in Surface area of a Chronic Pelvic Pressure Ulcer (PU) at 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.

  4 weeks

Secondary Outcomes (1)

• Percent Change in Surface area of a Chronic Pelvic Pressure Ulcer (PU) at 8 Weeks

  8 weeks

Study Arms (2)

Cefazolin Treatment

EXPERIMENTAL

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

Standard of Care Control

NO INTERVENTION

Subjects will not receive intervention and will receive standard of care for 8 weeks.

Interventions

Ultrasonic Distribution of Cefazolin DEVICE

Cefazolin Treatment

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female, age 18 to 79;
• Chronic (e.g., duration of injury at least 6 months), stable SCI (regardless of level of neurological lesion);
• American Spinal Injury Association Impairment Scale (AIS) designation of A or B with no sensation in the pelvic region;
• 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;
• At least one Stage III or IV PU in the pelvic region greater than 100 cm2 in surface area; and,
• Hemoglobin A1C ≤7.0%.

You may not qualify if:

• Persons who are candidates for or elect to have reconstructive flap surgery of the PU;
• 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;
• Hemoglobin A1C \>7.0%;
• 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;
• Acute illness or systemic infection;
• Allergy to cefazolin;
• Allergy to penicillin;
• 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;
• Previously diagnosed active malignant disease;
• Suspicion of skin cancer at the PU site (i.e., clinical evaluation is currently on-going);
• Life expectancy less than 12 months;
• Nephrosis, hemodialysis or chronic ambulatory peritoneal dialysis therapy;
• Moderate to high dose glucocorticoid administrations (i.e., ≥ 40 mg prednisone or equivalent steroid dose) within the past 3 months;
• Diminished mental capacity;
• Inability or unwillingness of subject to provide informed consent; or,

Sponsors & Collaborators

• James J. Peters Veterans Affairs Medical Center: lead

Study Sites (1)

James J. Peters VA Medical Center

The Bronx, New York, 10468, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Center Director

Study Record Dates

• First Submitted: October 15, 2015
• First Posted: October 22, 2015
• Study Start: January 1, 2017
• Primary Completion: November 22, 2017
• Study Completion: March 1, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

US (1)