NCT02584426

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: James J. Peters Veterans Affairs Medical Center · Federal
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Persons with spinal cord injury (SCI) are at increased risk of developing a Stage III or IV (full-thickness) pressure ulcer (PU). These wounds are associated with a tremendous personal and financial cost. An intervention that proves efficacious in the facilitation of healing this chronic medical condition would be of enormous medical, social, and economic benefit to persons with SCI and other cohorts with a difficult to heal PUs. From preliminary studies, it appears that hypodermoclysis (i.e., an interstitial infusion) with an antibiotic (i.e., cefazolin; a first generation cephalosporin) and subsequent dispersion with ultrasound throughout the wound recently has been shown in preliminary work to be efficacious in the treatment of infection, both recognized pathogenic organisms and those that have colonized the wound bed), which then appears to facilitate wound closure and success of standard surgical intervention. This approach to wound care represents a paradigm shift because previously it was assumed that nonpathogenic organism did not impede wound healing or skin graft survival. The investigators will test this novel approach to wound healing in persons with SCI who have a chronic PU of the pelvic region.

Conditions

• Spinal Cord Injury
• Chronic Pressure Ulcers

Interventions

Type	Name	Description
DEVICE	Ultrasonic Distribution of Cefazolin

Timeline

• Start date: 2017-01-01
• Primary completion: 2017-11-22
• Completion: 2022-03-01
• First posted: 2015-10-22
• Last updated: 2022-04-25

Locations

1 site across 1 country: United States