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 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.

Condition	Treatment or Intervention	Phase
Spinal Cord Injury	Procedure: Pulsatile Lavage	Phase II

Further Study Details: 

Expected Total Enrollment:  60

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Spinal Cord Injury

Ohio
      VA Medical Center, Cleveland,  Ohio,  United States; Recruiting

Study chairs or principal investigators

David Wolff, Ph.D. Special Assistant to the Director,  Prgram Analysis and Review Section (PARS), VA Rehabilitation Research & Development Service   
Wijegupta Ellepola, Program Analyst,  Program Analysis and Review Section (PARS), VA Rehabilitation Resaearch and Development Service   

Study ID Numbers:  A2803
Record last reviewed:  May 2002
Last Updated:  October 13, 2004
Record first received:  October 9, 2002
ClinicalTrials.gov Identifier:  NCT00047619
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08