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. Interim analysis of a prospective, randomized trial of vacuum-assisted closure versus the healthpoint system in the management of pressure ulcers. The beneficial toxicity paradox of antimicrobials in leg ulcer healing impaired by a polymicrobial flora: a proof-of-concept study. Randomized clinical trial of ascorbic acid in the treatment of pressure ulcers. Prospective randomized controlled study of Hydrofiber dressing containing ionic silver or calcium alginate dressings in non-ischaemic diabetic foot ulcers. A comparison of two dressings in the management of chronic wounds. Vacuum-assisted closure versus saline-moistened gauze in the healing of postoperative diabetic foot wounds. Bacterial load in relation to vacuum-assisted closure wound therapy: a prospective randomized trial.
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. Twenty-eight patients with 41 full-thickness decubitus ulcers were randomized to compare the Vacuum-Assisted Closure device (VAC) with the Healthpoint System (HP) of wound gel products in promoting ulcer healing. A total of 22 patients with 35 full-thickness ulcers completed the 6-week trial of treatment, during which time 2 patients (10%) in the VAC group (N =20) and 2 patients (13%) in the HP group (N = 15) healed completely. The mean percent reduction in ulcer volume was 42.1% with HP and 51.8% with VAC (p = 0.46). The mean number of PMNs and lymphocytes per high-power field decreased in the VAC group and increased in the HP group (p = 0.13, p = 0.41 respectively). The mean number of capillaries per high-power field was greater in the VAC group (p = 0.75). There were 15 cases of biopsy-proven osteomyelitis underlying the ulcers; three (37.5%) improved with VAC and none improved with HP (p = 0.25). VAC promotes an increased rate of wound healing and favorable histological changes in soft tissue and bone compared with HP. Some of the views contrasting the beneficial and toxic effects of antimicrobials upon wound healing remain controversial.
                To assess the clinical relevance of histological findings following antimicrobial applications on chronic leg ulcers.
                The present study was performed in three parallel groups of 17 patients suffering from at least 2 similar chronic leg ulcers. Clinical planimetric assessments were performed before and after 3 and 6 weeks of treatment using hydrocolloid dressings. In addition, 1 ulcer in each patient received applications of povidone-iodine (PVP-I), silver sulfadiazine or chlorhexidine digluconate. Histological examinations were made at inclusion and after the 6-week therapy. Time to healing was also recorded.
                At entry in the study, fibroblasts, macrophages, neutrophils and vessels were abundant in the ulcers. In addition, focal necrotizing vasculitis was related to the microbiological load. Compared to the control lesions, both the healing rate and time to healing of the leg ulcers showed a modest improvement at the sites receiving silver sulfadiazine (2-7%) or chlorhexidine digluconate (-1 to 5%). By contrast, PVP-I increased significantly the healing rate (4-18%, p < 0.01), and time to healing was reduced by 2-9 weeks (p < 0.01). The 3 antimicrobials decreased the bacterial density, and the vascular margination and migration of inflammatory cells, thus abating the vasculitic changes. PVP-I applications did not alter the microvessels and did not significantly reduce the density in dendrocytes and fibroblasts. By contrast, both silver sulfadiazine and chorhexidine digluconate appeared to alter the superficial microsvasculature including the dendrocyte population.
                Although topical antimicrobials may apparently achieve almost similar activity on the bacterial load inside chronic leg ulcers, the toxicity upon host cells was different among these agents. PVP-I appeared to be an efficient compound in these respects exhibiting a positive and relevant clinical effect.
                Copyright 2002 S. Karger AG, Basel The objective of this study was to assess the effects of ascorbic acid supplementation, 500 mg twice daily in the treatment of pressure ulcers as an adjunct to standardized treatment. The design consisted of a multicenter blinded randomized trial. The control group received 10 mg of ascorbic acid twice daily. Patients from 11 nursing homes and 1 hospital participated. Main outcome measures included wound survival, healing rates of wound surfaces, and clinimetric changes over 12 weeks. Eighty-eight patients were randomized. Intention-to-treat analysis showed that the wound closure probability per unit time (i.e., the closure rate) was not higher in the intervention group than in the control group (Cox hazard ratio of 0.78 [90% precision interval, 0.44-1.39]). Mean absolute healing rates were 0.21 and 0.27 cm2/week in the intervention and control group, respectively (PI of the adjusted difference: -0.17 to 0.13). Relative healing rates and healing velocities did not show favorable results of ascorbic acid supplementation, either. A panel scored slides of the ulcers with a report mark between 1 (bad) and 10 (excellent). The improvement was 0.45 and 0.72 points per week in the intervention and control group, respectively (PI of the adjusted difference: -0.50 to 0.20). With another clinimetric index we could not show any differences, either. These data do not support the idea that ascorbic acid supplementation (500 vs. 10 mg twice daily) speeds up the healing of pressure ulcers. Diabetic foot ulcers (DFUs) are at risk of infection and impaired healing, placing patients at risk of lower extremity amputation. DFU care requires debridement and dressings. A prospective, multicentre study compared clinical efficacy and safety of AQUACEL Hydrofiber dressings containing ionic silver (AQAg) with those of Algosteril calcium alginate (CA) dressings in managing out-patients with Type 1 or 2 diabetes mellitus and non-ischaemic Wagner Grade 1 or 2 DFUs.
                Patients stratified by antibiotic use on enrolment were randomly assigned to similar protocols including off-loading, AQAg (n = 67) or CA (n = 67) primary dressings and secondary foam dressings for 8 weeks or until healing. Clinical efficacy measures were healing outcomes and primarily healing speed. Adverse events were recorded.
                AQAg and CA groups were comparable at baseline. All ulcer healing outcomes improved in both groups. The mean time to healing was 53 days for AQAg ulcers and 58 days for CA ulcers (P = 0.34). AQAg-treated ulcers reduced in depth nearly twice as much as CA-treated ulcers (0.25 cm vs. 0.13 cm; P = 0.04). There was more overall ulcer improvement and less deterioration in AQAg subjects (P = 0.058), particularly in the subset initially using antibiotics (P = 0.02). Safety profiles of both groups were similar.
                When added to standard care with appropriate off-loading, AQAg silver dressings were associated with favourable clinical outcomes compared with CA dressings, specifically in ulcer depth reduction and in infected ulcers requiring antibiotic treatment. This study reports the first significant clinical effects of a primary wound dressing containing silver on DFU healing. A hydropolymer dressing (Tielle) and a hydrocolloid dressing (Granuflex) were compared in a randomised controlled clinical study involving 100 patients with leg ulcers and 99 patients with pressure sores in the community. Statistically significant differences in favour of the hydropolymer dressing were detected for dressing leakage and odour production, but no statistically significant differences were recorded in the number of patients with either leg ulcers or pressure sores who healed in each treatment group. Diabetic foot wounds present a great challenge to wound care practitioners. The objective of this pilot study was to determine whether vacuum-assisted closure (V.A.C.) therapy would afford quicker wound resolution as compared to saline-moistened gauze in the treatment of postoperative diabetic foot wounds. Ten patients were randomized into either the experimental V.A.C. group or control saline gauze group. Included in the study were diabetic patients 18 to 75 years of age who had a nonhealing foot ulceration. Excluded were those patients with venous disease, coagulopathy, or those who had active infections not resolved by initial surgical debridement. All foot ulcers were surgically debrided prior to initiation of V.A.C. or gauze treatment. In the experimental group, V.A.C. dressings were applied in accordance with manufacturer's protocol for chronic wounds and changed every 48 hours. In the control group, saline gauze dressings were applied at the time of surgical debridement and changed twice a day thereafter. Measurements and photos were obtained to document wound progress. Main outcome measures included: 1) time to satisfactory healing (calculated from date of initial debridement to date of definitive closure, and 2) change in wound surface area (calculated from initial wound tracing to final tracing). Satisfactory healing in the V.A.C. group was achieved in 22.8 (+/- 17.4) days, compared to 42.8 (+/- 32.5) days in the control group. Surface area changes of 28.4% (+/- 24.3) average decrease in wound size in the V.A.C. group, compared to a 9.5% (+/- 16.9) average increase in the control group during measurement period. Vacuum-assisted closure has become a new technique in the challenging management of contaminated, acute, and chronic wounds. Although promising clinical results have been described, scientific proof to substantiate the mechanism of action of this therapy is scarce. In the present study, we examined whether the positive effect on wound healing found in vacuum-assisted closure-treated wounds could be explained by an effect on the bacterial load. Fifty-four patients who needed open wound management before surgical closure were included in this study. Wounds were randomized to either vacuum-assisted closure therapy (n= 29) or treatment by conventional moist gauze therapy (n= 25). Healing was characterized by development of a clean granulating wound bed ("ready for surgical therapy") and reduction of wound surface area. To quantify bacterial load, biopsies were collected. No significant difference was found in time needed to reach "ready for surgical therapy" comparing both therapies. Wound surface area reduction was significantly larger in vacuum-assisted closure-treated wounds: 3.8 +/- 0.5 percent/day (mean +/- SEM) compared to conventional-treated wounds (1.7 +/- 0.6 percent/day; p < 0.05). The total quantitative bacterial load was generally stable in both therapies. However, nonfermentative gram negative bacilli showed a significant decrease in vacuum-assisted closure-treated wounds (p < 0.05), whereas Staphylococcus aureus showed a significant increase in vacuum-assisted closure-treated wounds (p < 0.05). In conclusion, this study shows a positive effect of vacuum-assisted closure therapy on wound healing, expressed as a significant reduction of wound surface area. However, this could not be explained by a significant quantitative reduction of the bacterial load.
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.