140 Open Label Pilot Study of Prolonged Release Nanocrystalline Silver Dressing (Acticoat 7): Reduction of Bacterial Burden Treatment in the Treatment of Chronic Venous Leg Ulcers
Bibliographic record
Abstract
In persons with venous ulcers and an absence of arterial disease, high compression as exemplified by the four layer bandage (Profore) has been demonstrated to be effective by a meta-analysis of existing studies. Despite optimized compression, some venous ulcers do not heal at the expected rate and persistent inflammation or infection may delay or prevent healing. We report the results of a case series that demonstrates an ionized silver dressing with prolonged release of nanocrystalline crystals (Acticoat 7) can decrease bacterial burden and accelerate healing in venous ulcers not healing at the expected rate. Patients with venous ulcers were treated with a prolonged release absorptive nanocrystalline silver dressing (Acticoat 7) under a four layer bandage (Profore) for 12 weeks, or until healing. The primary efficacy objective measured the effect of the silver dressing on the wound microflora. Biopsies of the wounds were taken at baseline and after treatment with the silver dressing (Acticoat 7) and were analyzed for the bacterial species and number of bacteria present. In addition, serum silver levels were assessed at baseline, weeks 4, 8 and week 12 or final assessment. A total of 15 patients (9 male, and 6 female) were enrolled into the study. The median age was 63 years (range 30–83 years). The median duration of current ulceration was 17.3 weeks (range 4 weeks to 11 years) and the median ulcer area was 4.8 cm2(range 1.8–43.9 cm2). The median exposure to Acticoat 7 was 82 days (range 8–86 days). There was a statistically significant reduction (p = 0.0114) in the log10(total bacterial count) between the baseline and final biopsies (median 4.48 and 3.00, respectively). Four patients healed, 8 patients continued to the end of the 12-week study period and three patients were discontinued early. Of those patients who did not heal, 4 had more than a 94% reduction in wound area by the end of the 12-week study period. For all patients, the median percentage reduction in ulcer area was 94.4% and the median final ulcer area was 0.4 cm2. Statistical analysis showed a significant increase (p = 0.054) in serum silver concentration during the treatment period. At baseline, prior to the silver dressing treatment (Acticoat 7), the median silver concentration was 0.3 μg/L (range: 0.20–1.90 μg/L). The median within patient change from baseline serum silver concentration was an increase of 0.15 μg/L (range: −0.3–2.8 μg/L). Although this small increase was observed it was not considered clinically significant. This study illustrates the use of prolonged release nanocrystalline silver dressing to decrease the bacterial burden of chronic venous ulcers not healing at the expected rate.
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How this classification was reachedexpand
Full frame distilled prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. Learned from the 10,348 direct Codex labels and 10,348 direct Gemma labels. Candidate is the union of thresholded teacher heads; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels or direct frontier model labels.
Codex and Gemma teacher scores by category
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.000 | 0.000 |
| Meta-epidemiology (narrow) | 0.000 | 0.000 |
| Meta-epidemiology (broad) | 0.000 | 0.000 |
| Bibliometrics | 0.000 | 0.000 |
| Science and technology studies | 0.000 | 0.000 |
| Scholarly communication | 0.000 | 0.000 |
| Open science | 0.000 | 0.000 |
| Research integrity | 0.000 | 0.000 |
| Insufficient payload (model declined to judge) | 0.000 | 0.000 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one teacher head, not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".