Enhancement of Pressure Healing With Pulsatile Lavage
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/21/2016 |
| Start Date: | June 2002 |
| End Date: | May 2008 |
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.
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.
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). It will investigate
the hypothesis that the treatment of non-necrotic pressure ulcers with pulsatile lavage will
enhance the rate of healing.
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.
healing of pressure ulcers in individuals with spinal cord injury (SCI). It will investigate
the hypothesis that the treatment of non-necrotic pressure ulcers with pulsatile lavage will
enhance the rate of healing.
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.
Inclusion Criteria:
Spinal Cord Injury
Exclusion Criteria:
systemic disease
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