BACKGROUND: Pressure ulcer development is a common, serious complication after spinal cord injury (SCI). Although many biophysical agents are available for treatment, few randomized controlled trials of their efficacy have been done. OBJECTIVE: The study objective was to examine the efficacy of low-pressure pulsatile lavage treatment for stage III and IV pressure ulcers in people with SCI. DESIGN: This study was a randomized controlled trial. Participants and assessors were unaware of intervention assignments. SETTING: This study was conducted in an SCI tertiary care center inpatient unit. PARTICIPANTS: Participants were 28 people with SCI and stage III and IV pelvic pressure ulcers; 14 participants each were randomly assigned to treatment and control (sham treatment) groups. INTERVENTION: Daily low-pressure pulsatile lavage treatment with 1 L of normal saline at 11 psi of pressure was applied to the treatment group along with standard dressing changes. The control group received only sham treatment and standard dressing changes. MEASUREMENTS: Linear and volume measurements of pressure ulcer dimensions were obtained weekly for 3 weeks. RESULTS: Statistical analysis with the t test revealed no statistically significant difference in demographics between groups. Random-coefficient models for analysis of linear and volume measurements revealed improvements over time for both groups. Time trend analysis revealed greater measurement decreases for the treatment group. Differences in rates of change (with 95% confidence intervals) for treatment and control groups, respectively, were: depth, -0.24 (0.09 to -0.58) cm/wk; width, -0.16 (0.06 to -0.39) cm/wk; length, -0.47 (0.18 to -1.12) cm/wk; and volume, -0.33 (0.13 to -0.80) cm(3)/wk. LIMITATIONS: Study limitations were small sample size and inclusion of only one site. Additionally, participants were not queried about their group assignments. CONCLUSIONS:Pulsatile lavage enhanced stage III and IV pelvic pressure ulcer healing rates in people with SCI relative to standard pressure ulcer treatment alone.
RCT Entities:
BACKGROUND: Pressure ulcer development is a common, serious complication after spinal cord injury (SCI). Although many biophysical agents are available for treatment, few randomized controlled trials of their efficacy have been done. OBJECTIVE: The study objective was to examine the efficacy of low-pressure pulsatile lavage treatment for stage III and IV pressure ulcers in people with SCI. DESIGN: This study was a randomized controlled trial. Participants and assessors were unaware of intervention assignments. SETTING: This study was conducted in an SCI tertiary care center inpatient unit. PARTICIPANTS: Participants were 28 people with SCI and stage III and IV pelvic pressure ulcers; 14 participants each were randomly assigned to treatment and control (sham treatment) groups. INTERVENTION: Daily low-pressure pulsatile lavage treatment with 1 L of normal saline at 11 psi of pressure was applied to the treatment group along with standard dressing changes. The control group received only sham treatment and standard dressing changes. MEASUREMENTS: Linear and volume measurements of pressure ulcer dimensions were obtained weekly for 3 weeks. RESULTS: Statistical analysis with the t test revealed no statistically significant difference in demographics between groups. Random-coefficient models for analysis of linear and volume measurements revealed improvements over time for both groups. Time trend analysis revealed greater measurement decreases for the treatment group. Differences in rates of change (with 95% confidence intervals) for treatment and control groups, respectively, were: depth, -0.24 (0.09 to -0.58) cm/wk; width, -0.16 (0.06 to -0.39) cm/wk; length, -0.47 (0.18 to -1.12) cm/wk; and volume, -0.33 (0.13 to -0.80) cm(3)/wk. LIMITATIONS: Study limitations were small sample size and inclusion of only one site. Additionally, participants were not queried about their group assignments. CONCLUSIONS: Pulsatile lavage enhanced stage III and IV pelvic pressure ulcer healing rates in people with SCI relative to standard pressure ulcer treatment alone.