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A Prospective, Randomized, Controlled Study to Evaluate the Effectiveness of a Fabric-Based Wireless Electroceutical Dressing Compared to Standard-of-Care Treatment Against Acute Trauma and Burn Wound Biofilm Infection

Chan, Rodney K., Nuutila, Kristo, Mathew-Steiner, Shomita S., Diaz, Victoria, Anselmo, Kristin, Batchinsky, Maria, Carlsson, Anders, Ghosh, Nandini, Sen, Chandan K., Roy, Sashwati·2024·Advances in Wound Care
DOI 10.1089/wound.2023.0007PMC PMC10654645
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Abstract

Objective: Despite advances in the use of topical and parenteral antimicrobial therapy and the practice of early tangential burn wound excision to manage bacterial load, 60% of the mortality from burns is attributed to bacterial biofilm infection. A low electric field (∼1 V) generated by the novel FDA-cleared wireless electroceutical dressing (WED) was previously shown to significantly prevent and disrupt burn biofilm infection in preclinical studies. Based on this observation, the purpose of this clinical trial was to evaluate the efficacy of the WED dressing powered by a silver–zinc electrocouple in the prevention and disruption of biofilm infection. Approach: : A prospective, randomized, controlled, single-center clinical trial was performed to evaluate the efficacy of the WED compared with standard-of-care (SoC) dressing to treat biofilms. Burn wounds were randomized to receive either SoC or WED. Biopsies were collected on days 0 and 7 for histology, scanning electron microscopy (SEM) examination of biofilm, and for quantitative bacteriological analyses. Results: In total, 38 subjects were enrolled in the study. In 52% of the WED-treated wounds, little to no biofilm could be detected by SEM. WED significantly lowered or prevented increase of biofilm in all wounds compared with the pair-matched SoC-treated wounds. Innovation: WED is a simple, easy, and rapid method to protect the wound while also inhibiting infection. It is activated by a moist environment and the electrical field induces transient and micromolar amounts of superoxide anion radicals that will prevent bacterial growth. Conclusion: WED decreased biofilm infection better compared with SoC. The study was registered in clinicaltrials.gov as NCT04079998.

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Rodney K. Chan, MD
Rodney K. Chan, MDCC BY · PubMed Central
Sashwati Roy, PhD
Sashwati Roy, PhDCC BY · PubMed Central
Figure 1. (A) WED consisting of a silver–zinc electrocouple to generate a low electric field (∼1 V) that induces transient and micromolar amounts of superoxide anion radicals (copyright permissions obtained; right panel image originally published in Banerjee et al.32). The dressing becomes activated by a moist environment. (B) The WED placed on burn wounds: Alone (left) and next to standard of care treatment (right). WED, wireless electroceutical dressing.
Figure 1. (A) WED consisting of a silver–zinc electrocouple to generate a low electric field (∼1 V) that induces transient and micromolar amounts of superoxide anion radicals (copyright permissions obtained; right panel image originally published in Banerjee et al.32). The dressing becomes activated by a moist environment. (B) The WED placed on burn wounds: Alone (left) and next to standard of care treatment (right). WED, wireless electroceutical dressing.CC BY · PubMed Central
Figure 2. Study enrollment, randomization, and follow-up. (A) Of the 38 subjects with burns that completed the short-term study, 25 had complete data sets for further analysis. (B) Treatment design: For the first 7 days following burn, following randomization, patients received either SoC or WED at the site of burn. After this period of treatment, WED was discontinued and SoC alone was applied until completion of the study at day 30. SoC, standard of care.
Figure 2. Study enrollment, randomization, and follow-up. (A) Of the 38 subjects with burns that completed the short-term study, 25 had complete data sets for further analysis. (B) Treatment design: For the first 7 days following burn, following randomization, patients received either SoC or WED at the site of burn. After this period of treatment, WED was discontinued and SoC alone was applied until completion of the study at day 30. SoC, standard of care.CC BY · PubMed Central
Figure 3. WED significantly decreased biofilm severity in all burn patients. (A) Biofilm grading rubric. Each sample was divided into five ROIs (LI, L2, C, R1, R2) as shown. Multiple images (n = 3–4) were taken from each area to minimize bias. Grading was performed following a 0–3 grade rubric where 0 = no biofilm or EPS and 3 = abundant biofilm and EPS in >75% of the sample. (B) Representative SEM images from day 0 and 7 of SoC or WED-treated burn patients. Red arrowheads point to biofilm EPS matrix containing bacteria. Blinded biofilm grading was performed on SEM images obtained from (C) all wounds (n = 25), (D) nongrafted wounds (n = 12), and (E) grafted wounds (n = 13). Change in grade between days 0 and 7 are represented as percentages in the graphs. WED-treated burn patients had significantly lower biofilm grade compared with SoC alone. Contingency analysis using Fisher's exact test was performed. *p < 0.05, ***p < 0.0001, ****p < 0.00001. EPS, extracellular polymeric substances; ROI, region of interest; SEM, scanning electron microscopy.
Figure 3. WED significantly decreased biofilm severity in all burn patients. (A) Biofilm grading rubric. Each sample was divided into five ROIs (LI, L2, C, R1, R2) as shown. Multiple images (n = 3–4) were taken from each area to minimize bias. Grading was performed following a 0–3 grade rubric where 0 = no biofilm or EPS and 3 = abundant biofilm and EPS in >75% of the sample. (B) Representative SEM images from day 0 and 7 of SoC or WED-treated burn patients. Red arrowheads point to biofilm EPS matrix containing bacteria. Blinded biofilm grading was performed on SEM images obtained from (C) all wounds (n = 25), (D) nongrafted wounds (n = 12), and (E) grafted wounds (n = 13). Change in grade between days 0 and 7 are represented as percentages in the graphs. WED-treated burn patients had significantly lower biofilm grade compared with SoC alone. Contingency analysis using Fisher's exact test was performed. *p < 0.05, ***p < 0.0001, ****p < 0.00001. EPS, extracellular polymeric substances; ROI, region of interest; SEM, scanning electron microscopy.CC BY · PubMed Central
Figure 4. WED significantly decreased bacterial load in nongrafted burn patients. Blinded semiquantitative scoring of bacterial load was performed on (A) all wounds (n = 21) and (B) nongrafted wounds (n = 10). Change in score between days 0 and 7 are represented as percentages in the graphs and showed that nongrafted, WED-treated burn patients had significantly lower bacterial load compared with SoC alone. Contingency analysis using Fisher's exact test was performed. ****p < 0.0001; NS = not significant.
Figure 4. WED significantly decreased bacterial load in nongrafted burn patients. Blinded semiquantitative scoring of bacterial load was performed on (A) all wounds (n = 21) and (B) nongrafted wounds (n = 10). Change in score between days 0 and 7 are represented as percentages in the graphs and showed that nongrafted, WED-treated burn patients had significantly lower bacterial load compared with SoC alone. Contingency analysis using Fisher's exact test was performed. ****p < 0.0001; NS = not significant.CC BY · PubMed Central
Figure 5. WED significantly decreased the incidence of specific opportunistic bacterial pathogenic strains in burn patients. Blinded semiquantitative scoring of incidence of (A) Ralstonia pickettii (n = 5) and (B) Serratia marcescens (n = 11) was performed. Percentage of samples containing the bacterial strains between days 0 and 7 is represented in the graphs. WED-treated burn patients had significantly fewer R. picketti (***p < 0.0001) or S. marcescens (*p < 0.05) compared with SoC alone. Contingency analysis using Fisher's exact test was performed.
Figure 5. WED significantly decreased the incidence of specific opportunistic bacterial pathogenic strains in burn patients. Blinded semiquantitative scoring of incidence of (A) Ralstonia pickettii (n = 5) and (B) Serratia marcescens (n = 11) was performed. Percentage of samples containing the bacterial strains between days 0 and 7 is represented in the graphs. WED-treated burn patients had significantly fewer R. picketti (***p < 0.0001) or S. marcescens (*p < 0.05) compared with SoC alone. Contingency analysis using Fisher's exact test was performed.CC BY · PubMed Central
Figure 6. Acute treatment with WED does not adversely affect burn wound closure or quality. (A) Quantitation of wound closure at days 14 and 30 using digital planimetry. (B) Quantitation of TEWL at days 14 and 30. No significant differences were observed. WED-SoC = WED treatment. (C) Vancouver Scar Scale Measurements, (D) POSAS. POSAS, Patient Observer Scar Assessment Scale; TEWL, transepidermal water loss.
Figure 6. Acute treatment with WED does not adversely affect burn wound closure or quality. (A) Quantitation of wound closure at days 14 and 30 using digital planimetry. (B) Quantitation of TEWL at days 14 and 30. No significant differences were observed. WED-SoC = WED treatment. (C) Vancouver Scar Scale Measurements, (D) POSAS. POSAS, Patient Observer Scar Assessment Scale; TEWL, transepidermal water loss.CC BY · PubMed Central
Figure 7. Summary graphic. In this study, patients with burn wounds admitted to the Brooke Army Medical Center (San Antonio TX), were subject to short-term (7 days) treatment with a WED. WED was more efficient in inhibiting biofilm infection compared with standard of care. Proposed mechanisms of action are described in prior publications from this group. The images were purchased and used per standard agreement policy from iSTOCK.com.
Figure 7. Summary graphic. In this study, patients with burn wounds admitted to the Brooke Army Medical Center (San Antonio TX), were subject to short-term (7 days) treatment with a WED. WED was more efficient in inhibiting biofilm infection compared with standard of care. Proposed mechanisms of action are described in prior publications from this group. The images were purchased and used per standard agreement policy from iSTOCK.com.CC BY · PubMed Central

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Citations

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Metadata

Authors
Chan, R. K., Nuutila, K., Mathew-Steiner, S. S., Diaz, V., Anselmo, K., Batchinsky, M., Carlsson, A., Ghosh, N., Sen, C. K., & Roy, S.
Venue
Advances in Wound Care
Publisher
SAGE Publications
Published
2023-11-03
Volume
13
Issue
1
Pages
1-13
ISSN
  • 2162-1918
  • 2162-1934
DOI
10.1089/wound.2023.0007
PMC
PMC10654645
Cited by
24
References
1
Language
en
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