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We will describe results from a clinical evaluation which was conducted on non-adhesive absorbent 3-layer silver barrier dressings* in conjunction with 4-layer compression therapy,** in patients with bacterially colonized venous leg ulcers and defines clinical outcomes observed over a 12 week period.
The Study
· 25 patient clinical evaluation.
· Primary objective is assessment of percentage of patients achieving reduction in total bioburden from ≥105 cfu/g to <105 cfu/g tissue.
· Secondary objectives include changes in bioburden within the wounds, reduction in ulcer area and angiogenic factor analysis over the 12 week study follow-up.
Methodology
Single center, IRB approved study. Male/female patients, >18 years old, >4cm2, >4 week old venous leg ulcer, with low to moderate exudate, at least one clinical sign of infection and ≥105 cfu/g tissue. Wounds were assessed weekly with tissue biopsies at weeks 0, 2, 4 & 8.
Results
Twelve patients included in interim results. Full results will be presented at the conference.
· Baseline characteristics
o Age (mean = 63.2 years, range 45 – 82 years)
o 10 Men, 2 Women
o ABI (mean = 1.2, range 0.8 – 1.4)
o Ulcer duration (median = 52 days, range 13 – 208 days)
o Ulcer area (median = 14.3 cm2, range 4.8 – 128.3 cm2)
o Bioburden (mean/median = 5.5 log10 cfu/g tissue, range 5.1 – 5.7 log10 cfu/g tissue)
· Reduction in bioburden
o 9/12 (75%) patients achieved <105 cfu/g tissue after 8 weeks
o Significant evidence of a reduction in bacterial load after 8 weeks (p<0.001, median reduction= 5.3 log10 cfu/g tissue, mean reduction = 3.4 log10 cfu/g tissue, range 0.4 to 5.7 log10 cfu/g tissue)
· 8/12 (66.7%) ulcers closed
Conclusion
Results of this study suggest non-adhesive absorbent 3-layer silver barrier dressings* in conjunction with 4-layer compression therapy** may be effective in reducing bacterial load in bacterially colonized venous leg ulcers.
The Study
· 25 patient clinical evaluation.
· Primary objective is assessment of percentage of patients achieving reduction in total bioburden from ≥105 cfu/g to <105 cfu/g tissue.
· Secondary objectives include changes in bioburden within the wounds, reduction in ulcer area and angiogenic factor analysis over the 12 week study follow-up.
Methodology
Single center, IRB approved study. Male/female patients, >18 years old, >4cm2, >4 week old venous leg ulcer, with low to moderate exudate, at least one clinical sign of infection and ≥105 cfu/g tissue. Wounds were assessed weekly with tissue biopsies at weeks 0, 2, 4 & 8.
Results
Twelve patients included in interim results. Full results will be presented at the conference.
· Baseline characteristics
o Age (mean = 63.2 years, range 45 – 82 years)
o 10 Men, 2 Women
o ABI (mean = 1.2, range 0.8 – 1.4)
o Ulcer duration (median = 52 days, range 13 – 208 days)
o Ulcer area (median = 14.3 cm2, range 4.8 – 128.3 cm2)
o Bioburden (mean/median = 5.5 log10 cfu/g tissue, range 5.1 – 5.7 log10 cfu/g tissue)
· Reduction in bioburden
o 9/12 (75%) patients achieved <105 cfu/g tissue after 8 weeks
o Significant evidence of a reduction in bacterial load after 8 weeks (p<0.001, median reduction= 5.3 log10 cfu/g tissue, mean reduction = 3.4 log10 cfu/g tissue, range 0.4 to 5.7 log10 cfu/g tissue)
· 8/12 (66.7%) ulcers closed
Conclusion
Results of this study suggest non-adhesive absorbent 3-layer silver barrier dressings* in conjunction with 4-layer compression therapy** may be effective in reducing bacterial load in bacterially colonized venous leg ulcers.