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KMID : 1144920190150010005
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Journal of Wound Management and Research
2019 Volume.15 No. 1 p.5 ~ p.10
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Portable Ultrasonic Surgery System for Chronic Wounds: A Multicenter Randomized Controlled Clinical Trial and In Vitro Characterization
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Pak Chang-Sik
Lim Joon-Ho
Kim Baek-Kyu
Kim Hyeon-Woo
Park Su-Yeon
Mun Goo-Hyun
Kim Jeong-Tae
Jeong Jae-Hoon
Heo Chan-Yeong
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Abstract
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Background: Debridement is a crucial process in wound care. Low-frequency ultrasound debridement is a relatively painless modality that eliminates necrotic tissue, decreases bacterial counts, and minimizes blood loss. ULSC-12D is a lightweight and compact ultrasound surgery system, and SONOCA 180 is a larger conventional system. We compared the efficacy and safety of these two devices in a multicenter randomized controlled clinical trial and conducted relevant in vitro studies.
Methods: Thirty patients were enrolled in the clinical trial and randomly allocated to two groups: the study group undergoing debridement using ULSC-12D and the control group undergoing debridement using SONOCA 180. Intra-procedural pain and post-procedural reduction of bacteria and necrotic tissue were evaluated. Experimental in vitro studies were performed with three groups: cells treated with ULSC-12D, cells treated with SONOCA 180, and a control group. Cell proliferation, collagen synthesis, growth factor expression, and nitric oxide production were measured.
Results: There were no significant differences in outcome between two clinical trial groups. Both devices provided acceptable necrotic tissue and bacterial reduction, and no significant adverse events were reported. In in vitro studies, ULSC-12D-treated fibroblasts produced significantly more collagen and basic fibroblast growth factor. Fibroblast proliferation rate and endothelial cell nitric oxide production were significantly higher in ultrasound-treated cells, but the differences between device groups were not significant.
Conclusion: ULSC-12D is as effective and safe as the more conventional SONOCA 180 for wound debridement and yields superior results to SONOCA 180 in in vitro studies.
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KEYWORD
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Ultrasonic therapy, Debridement, Pressure ulcer, Surgical equipment
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