Pulsatile lavage for the enhancement of pressure ulcer healing: a randomized controlled trial. Evaluation of a silver-releasing hydroalginate dressing in chronic wounds with signs of local infection.
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.
                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.
                This study was a randomized controlled trial. Participants and assessors were unaware of intervention assignments.
                This study was conducted in an SCI tertiary care center inpatient unit.
                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.
                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.
                Linear and volume measurements of pressure ulcer dimensions were obtained weekly for 3 weeks.
                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.
                Study limitations were small sample size and inclusion of only one site. Additionally, participants were not queried about their group assignments.
                Pulsatile lavage enhanced stage III and IV pelvic pressure ulcer healing rates in people with SCI relative to standard pressure ulcer treatment alone. To evaluate the clinical impact of using a silver-releasing hydroalginate dressing to minimise the risk of local infection in colonised chronic wounds.
                This was a randomised (stratification according to wound type) open-label multicentre comparative two-arm parallel-group study. Thirteen centres recruited 99 patients with either a venous leg ulcer or a pressure ulcer. None of the wounds required systemic antibiotics or were associated with lymphangitis and/or fever, but at least two of the following criteria had to be present: continuous pain; erythema; oedema; heat; and moderate to high levels of serous exudate. Patients were allocated to receive either a silver-releasing hydroalginate dressing (Silvercel, the test group) or a pure calcium alginate dressing (Algosteril, the control group). Wounds were assessed daily over 14 days to complete a modified ASEPSIS index to evaluate risk of infection, and then weekly for two additional weeks. A global wound severity score and area tracings were recorded weekly.
                Fifty-one and 48 patients were randomised in the test and control groups respectively: 28 pressure ulcers and 71 venous leg ulcers. The total mASEPSIS score over 14 days did not differ significantly between groups: 95.4 +/- 62.2 and 104.2 +/- 72.8 in control and test groups respectively (p = 0.791). Of the patients who completed the total four-week study duration, four out of 38 (10.5%) in the control group and none of the 40 in the test group were treated with systemic antibiotics at the final visit (p = 0.053). According to the investigators, fewer wounds developed a clinical infection over the four-week follow-up in the test group (33% versus 46%; p = 0.223). Overall, the four-week closure rate was statistically greater in the test group (0.32 +/- 0.57cm2/day versus 0.16 +/- 0.40cm2/day; p = 0.024). Compared with baseline, the absolute decrease in wound severity score at week four was higher in the test group (-5.6 +/- 3.2 versus -4.1 +/- 4.3; p = 0.063); this was also true of the percentage reduction (-32 +/- 17% versus -23 +/- 25%; p = 0.034). Poor dressing acceptability and/or tolerability was noted in five out of 48 patients (10.4%) in the control group and in five out of 51 (9.8%) in the test group.
                This study suggests that the use of silver-releasing dressings in the management of wounds at high risk of infection may have a clinically favourable influence on wound prognosis; the dressings also appeared to be well tolerated. However, the evaluation of these advantages in controlled clinical trials is complex and requires potent studies and the development of more specific endpoints than those currently used.
We identified three small studies addressing cleansing of pressure ulcers. One reported a statistically significant improvement in pressure ulcer healing for wounds cleansed with saline spray containing Aloe vera, silver chloride and decyl glucoside (Vulnopur) compared with isotonic saline solution, a further study reported no statistically significant change in healing was seen when wounds were cleaned with water was compared with saline. A final study compared pulsatile lavage with sham and found a significantly greater reduction in ulcer volume at the end of the study period in the lavage group compared with the sham group. The authors conclude that there is no good trial evidence to support use of any particular wound cleansing solution or technique for pressure ulcers.