Spinal Cord InjuryNCT02584426
Subcutaneous Injection and Ultrasonic Dispersion of Cefazolin Into Chronic Pelvic-Region Pressure Ulcers in Persons With Spinal Cord Injury
A study testing Ultrasonic Distribution of Cefazolin in people with Spinal Cord Injury and Chronic Pressure Ulcers, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Spinal Cord Injury, Chronic Pressure Ulcers
- What is being tested?
- Ultrasonic Distribution of Cefazolin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2017to Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%.
Who cannot join
- 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;
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- 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,
- Pregnancy or women who may become pregnant during the course of the study, or those who are nursing.
Trial locations and contacts
1 site in 1 country.
United States1 site
James J. Peters VA Medical Center
The Bronx, New York, 10468
About this study
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.
Read the 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
- Being tested
- Ultrasonic Distribution of Cefazolin
- Keywords
- Cefazolin
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasonic Distribution of CefazolinDevice
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent Change in Surface area of a Chronic Pelvic Pressure Ulcer (PU) at 4 Weeks
- 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.
Measured: 4 weeks
Secondary outcomes (1)
Percent Change in Surface area of a Chronic Pelvic Pressure Ulcer (PU) at 8 Weeks
- 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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2015 (estimated)
- Study startJan 2017
- Primary completion22 Nov 2017
- Study completionMar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- James J. Peters Veterans Affairs Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, William A. Bauman, M.D., James J. Peters Veterans Affairs Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02584426
- Sponsor's protocol ID
- BAU-15-043
- Status last verified
- Apr 2022
- First submitted
- 15 Oct 2015
- Last updated
- 25 Apr 2022
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subcutaneous Injection and Ultrasonic Dispersion of Cefazolin Into Chronic Pelvic-Region Pressure Ulcers in Persons With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02584426
- Acronym / sponsor ID
- BAU-15-043
- Conditions
- Spinal Cord Injury, Chronic Pressure Ulcers
- Keywords
- Cefazolin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- James J. Peters Veterans Affairs Medical CenterUS federal agency
- Study start
- Jan 2017 (actual)
- Primary completion
- 22 Nov 2017 (actual)
- Study completion
- Mar 2022 (actual)
- First posted
- 22 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cefazolin Treatment | Experimental | Device: Ultrasonic Distribution of CefazolinSubjects will receive antibiotic treatment with phonophoresis (i.e., hypodermoclysis) during test 1, and will be given standard of care for 8 weeks. |
| Standard of Care Control | No intervention | –Subjects will not receive intervention and will receive standard of care for 8 weeks. |
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (16 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasonic Distribution of Cefazolin | Device | Cefazolin Treatment |
Primary outcome
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.
1 secondary outcome
Percent Change in Surface area of a Chronic Pelvic Pressure Ulcer (PU) at 8 Weeks
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonic Distribution of Cefazolin in people with Spinal Cord Injury and Chronic Pressure Ulcers, run by James J. Peters Veterans Affairs Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Change in Surface area of a Chronic Pelvic Pressure Ulcer (PU) at 4 Weeks (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.