Decreasing Pain and Increasing the Rate of Chronic Wound Closure With the Use of a Noninvasive Bioelectronic Medical Device

A Case Series

David Charles Hatch, DPM; Michael Lavor, MD

Disclosures

Wounds. 2021;33(5):119-126. 

In This Article

Abstract and Introduction

Abstract

Introduction: Chronic wounds are a source of significant morbidity. Medical and scientific efforts are ongoing to further therapeutic modalities improving pain scores and augmenting healing while decreasing complications and reducing the social and economic burden of wounds. Electrical current therapy, or electrical stimulation (ES), has been shown to decrease and modulate both acute and chronic pain; however, understanding of the role of ES in wound closure is limited.

Objective: This single-center case series reports use of a topical ultrahigh frequency ES (UHF-ES) therapy to decrease wound pain and improve the rate of closure in difficult-to-heal wounds in 9 patients.

Materials and Methods: Initially, each patient underwent individualized care of their chronic wounds for a minimum of 8 weeks, after which adjunct UHF-ES therapy was provided 3 times per week for an average of 8 additional weeks. Wound size and pain level were documented for the period before and after UHF-ES.

Results: Overall, pain improved across the 9 patients. One patient was insensate, and another experienced an increase in pain during treatment. Of the 8 patients with sensation, 7 (88%) experienced a decrease in wound pain, with an average 3.4-point reduction per 10-point visual analog scale. Average pain level was 4.14 before treatment and 0.71 after. The average wound size was 5.70 cm2 ± 5.23 cm2 approximately 8 weeks before the initiation of treatment, 4.34 cm2 ± 4.51 cm2 at the time of treatment, and 1.2 cm2 ± 1.75 cm2 at the conclusion of treatment. The average percentage of wound closure with individualized wound care alone was 23.77%, which increased to 64.58% with the addition of UHF-ES therapy. The weekly percentage of wound closure was statistically significant (P = .0027) between the 2 treatment methods.

Conclusions: While additional research into the use of ES (namely, UHF-ES in wound healing) is warranted, the device reported herein may be an effective, safe, and low-cost adjunct treatment in the care of chronic, difficult-to-heal wounds.

Introduction

The incidence of chronic wounds continues to increase in the United States, and the economic and physical demands of healing on patients are overwhelming. Over 8.2 million Medicare beneficiaries are being treated for at least one type of wound or wound-related infection, and up to 12 million people in the United States have a chronic wound of any type.[1,2]

Lower extremity ulcers are common, secondary to venous insufficiency and diabetes. Venous leg ulcers affect nearly 2% of the US population, and the prevalence of a foot ulcer in individuals with diabetes is as high as 13%.[3,4] Chronic wounds are an additional complication secondary to surgical interventions, and the prevalence of incision dehiscence after spinal surgery has been reported to be as high as 15%.[5,6] Furthermore, while an estimated 2 million people in the United States are newly diagnosed with cancer annually, about 50% will undergo radiation therapy, with subsequent therapy-related skin complications reportedly in as many as 95% of these individuals.[7–11]

The cost of wound care continues to rise. In 2018, Nussbaum et al[1] calculated Medicare costs for wound care (all types) to be between $28.1 billion and $96.8 billion in 2015 alone. While hospitalization for the treatment of chronic wounds and associated complications can be costly, the financial burden of hospitalization ($5.0 billion–$24.3 billion) was remarkably less onerous than the cost of outpatient wound care ($9.9 billion–$35.8 billion).[1] At least one catalyst in the dramatically rising cost of wound healing is the wound closure product market. Wound care products permeate both outpatient and hospital settings, and market analysis reports expect the financial impact of closure products to exceed $15 billion annually by 2022.[12]

Reducing cost while discovering wound closure modalities that promote healing and decrease morbidity is a scientific and medical imperative. This case series explores the improvement in pain levels and the rate of healing of chronic wounds before and after the use of ultrahigh frequency electrical stimulation (UHF-ES) as a novel adjunct therapy to normal regimented wound care.

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