Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
28 participants
INTERVENTIONAL
2002-06-30
2008-05-31
Brief Summary
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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.
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Detailed Description
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These 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 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.
Methodology Eligible individuals with SCI who are admitted to CVAMC with pelvic region pressure ulcers will be assigned to a pulsatile lavage treatment group or to a second non-intervention control group. A comprehensive assessment methodology will be employed to characterize pressure ulcer healing. All study participants will be assessed at routine intervals using objective measurement techniques. Statistical analysis of inter-group differences will allow the efficacy of pulsatile lavage for pressure ulcer healing to be established. Forty subjects will be enrolled in the study.
Patient Selection Criteria: 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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Pulsatile lavage group
pulsatile lavage therapy
Pulsatile Lavage
pulsatile lavage to wound bed
Sham lavage group
sham pulsatile lavage
sham pulsatile lavage
pulsatile lavage to not directed at wound or patient
Interventions
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Pulsatile Lavage
pulsatile lavage to wound bed
sham pulsatile lavage
pulsatile lavage to not directed at wound or patient
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
ALL
No
Sponsors
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US Department of Veterans Affairs
FED
Responsible Party
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Principal Investigators
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Chester H. Ho, MD
Role: PRINCIPAL_INVESTIGATOR
VA Medical Center-Cleveland
Locations
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VA Medical Center, Cleveland
Cleveland, Ohio, United States
Countries
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References
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Ho CH, Bensitel T, Wang X, Bogie KM. Pulsatile lavage for the enhancement of pressure ulcer healing: a randomized controlled trial. Phys Ther. 2012 Jan;92(1):38-48. doi: 10.2522/ptj.20100349. Epub 2011 Sep 23.
Other Identifiers
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A2803-R
Identifier Type: -
Identifier Source: org_study_id
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