Spinal Cord Injury Clinical Trial
Official title:
Enhancement of Pressure Healing With Pulsatile Lavage
The purpose of this study is to investigate the use of pulsatile lavage to enhance the
healing of pressure ulcers in individuals with spinal cord injury (SCI).
The goals will be achieved using a repeated-measures double-blinded randomized controlled
study of individuals with SCI who have pelvic region pressure ulcers. A total of 60 subjects
will be recruited to this study. Participants will be randomly assigned to a treatment or
control group. Pulsatile lavage treatment will be administered to the treatment group daily
for a 3 week period. The control group subjects will receive daily sham pulsatile lavage
treatment for 3 weeks. All subjects will be monitored for a 3 week period and will continue
to receive routine pressure ulcer care, i.e. dressings and bedrest with a regular turning
regime during their participation in the study.
All study participants will be monitored following the study period until complete closure
of the pressure ulcer is achieved in order to determine total interval to final closure,
including any surgical procedures required. In addition, the economic effects of pulsatile
lavage treatment will be evaluated through monitoring of data collected in the Computerized
Patient Record System (CPRS), including duration of admission, duration of total bedrest
order and duration of treatment for pressure ulcer. This data will give an initial measure
of the cost benefits that may be achieved with the use of pulsatile lavage for the treatment
of pressure ulcers.
Subjects will be recruited from the Louis Stokes Cleveland Veterans Affairs Medical Center
(CVAMC). All individuals with spinal cord injury who are admitted to the SCI Unit with
pelvic region pressure ulcers will be considered eligible for this study. Further selection
criteria will be employed to screen potential participants as described below. On
recruitment subjects will be randomly assigned to 2 groups of 20 subjects. The assessment
methods employed will be the same for each volunteer. One group will participate in the
pulsatile lavage intervention, the second group will act as controls.
Status | Completed |
Enrollment | 28 |
Est. completion date | May 2008 |
Est. primary completion date | May 2008 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: Spinal Cord Injury Exclusion Criteria: systemic disease |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | VA Medical Center, Cleveland | Cleveland | Ohio |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Pressure Ulcer Geometry | Linear assessment of wounds | study participation - up to 6 weeks | No |
Primary | Pressure Ulcer Volume Measurement | Volume of pressure ulcer was measured by the amount of fluid that could be used to fill the pressure ulcer which was covered by an occlusive dressing | study participation - up to 6 weeks | No |
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