Ignite Creation Date:
2024-05-05 @ 11:27 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00047619
Status:
COMPLETED
Last Update Posted:
2015-10-05
First Post:
2002-10-09
Brief Title:
Enhancement of Pressure Healing With Pulsatile Lavage
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Enhancement of Pressure Healing With Pulsatile Lavage
Status:
COMPLETED
Status Verified Date:
2015-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 ie 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 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 ie 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
Detailed Description:
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 ie 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
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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None