Stimulation of Wounds With an Electrical Stimulation Device
Stimulation of Wounds With an Electrical Stimulation Device
Ninety-five patients (68% men) were evaluated by ITT and 45 patients by PV, with a mean age in the ITT population of 69.1 ± 12.6 years. All cases were considered to be refractory to standard wound treatment and had been treated previously for an average of 13.7 months. A majority were vascular wounds (n = 62, 65.3%), followed by diabetic foot ulcers (n = 14, 14.7%), and pressure ulcers (n = 2, 2.1%). The remaining comprised various wounds (n = 14, 17.9%) that were mainly postoperative. The wounds were located overwhelmingly on the lower leg or foot (Figure 2). The mean duration of EST was 48.1 days.
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Figure 2.
Distribution of the wound sites under EST (n = 95).
Granulation and epithelialization increased markedly under EST, which was determined by evaluating the scaled wound photos (Figure 3). The proportion of wounds without granulation decreased from 17% to 0% in the ITT evaluation, and complete granulation was achieved in 30.4% of the wounds. The proportion of wounds with epithelialization increased in the total group from 15.4% to 80.4%. The effects were more apparent in the patients observed throughout the entire study (PV analysis); the number of wounds that re-epithelialized increased in this group from 8.9% to 80% (Figure 3). The mean wound area was 44.7 cm2, which decreased over the course of EST to 24.5 cm2 (Figure 4).
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Figure 3.
Granulation and epithelialization, comparison of all registered patients (n = 95) with patients with a complete data set (n = 45), (ITT vs. PP analysis), scaling 0 = none, 1 = 25%, 2 = 50%, 3 = 75%, 4 = 100%.
T1 = Before treatment
T2 = Follow-up after 2–6 weeks
T3 = Follow-up after 8–12 weeks or treatment discontinuation
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Figure 4.
Figure 4. Mean wound area in cm (all registered patients, n = 95).
T1 = Before treatment
T2 = Follow-up after 2–6 weeks
T3 = Follow-up after 8–12 weeks or treatment discontinuation
The proportion of patients with wound odor decreased in the total group from 44.0% at T1 to 26.1% at T3 (Figure 5).
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Figure 5.
Proportion of patients with/without wound odor over the course of therapy (all registered patients, n = 95).
T1 = Before treatment
T2 = Follow-up after 2–6 weeks
T3 = Follow-up after 8–12 weeks or treatment discontinuation
The condition of the wound margins improved under EST and was described as unirritated, reddened, edematous, macerated, reddened and edematous, reddened and macerated, reddened and necrotic, edematous and macerated, or macerated and livid. The proportion of unirritated wound margins increased markedly by a half (48.8%), while that of reddened margins fell by about half (51.9%). Macerations were relatively common with EST therapy, remaining constant at about one-third (T1 27.5%, T2 33,3%, T3 28.5%; Figure 6).
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Figure 6.
Assessment of the wound margins (all registered patients, n = 95). The chart shows the percentage of patients with the respective variable.
T1 = Before treatment
T2 = Follow-up after 2–6 weeks
T3 = Follow-up after 8–12 weeks or treatment discontinuation
Periwound condition was assessed on a 10-point scale (unirritated, reddened, edematous, macerated, dry, scaly, reddened and edematous, reddened and macerated, edematous and macerated, edematous and scaly). The proportion of wounds with healthy periwound skin increased from T1 with 20.9% to T3 with 60.9%.
Overall, the number of secreting wounds declined from 88% to 70.6%. Above all, however, the amount of exudate decreased, and the proportion of wounds with moderate to profuse exudation decreased from 47.1% to 17.4% (Table 2).
The proportion of patients with wound surface fibrin or necrosis decreased markedly from T1 to T3: 85% of the wounds exhibited fibrin or necrosis at T1 compared to 25% at T3. Additionally, the proportion of wounds with no fibrin or necrosis increased from 5.5% to 41.3%.
Wound-related pain was measured at rest, during exercise (normal daily activities), and during dressing changes. It was greatest during exercise at the start of the observation (T1) with a mean of 4.3; it was 2.4 at rest, and 2.6 during dressing change. Pain intensity decreased markedly on the VAS during EST by an average of 0.9 point at rest, by 2.0 during exercise, and by 0.9 during dressing change (Figure 7).
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Figure 7.
Wound pain at rest, during exercise, and during dressing changes (all registered patients, n = 95). T1 = Before treatment
T2 = Follow-up after 2–6 weeks
T3 = Follow-up after 8–12 weeks or treatment discontinuation
The global effectiveness of EST was described as "good" or "very good" by 74% of the patients, while the treatment was described as "good" by 48.1% and as "very good" by 29.1% (Figure 8).
A majority of patients were also satisfied with the tolerability of EST, with 78.5% describing it as "good" or "very good" (54.4% and 24.1 %, respectively; Figure 8).
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Figure 8.
Global assessment of the effectiveness and tolerability of electrical stimulation using an ESD (all registered patients, n = 95).
Adverse events occurred in a total of 38 patients by the end of the study; they included 13 cases of mesh graft or flap graft, which automatically led to their exclusion from the study, although these were not adverse events per se. One or more adverse events were recorded in 37.3% of patients at T2 and in 14.6% at T3. There were 12 patients for whom it was not documented whether adverse events had occurred.
Side effects (ie, adverse events that were directly associated with EST) included skin reactions to the dispersive electrode (n = 4), irritation of the periwound skin (n = 4), and maceration (n = 1). An expert performed a retrospective assessment of whether an association existed between EST and the side effects.
Deterioration of the wound status occurred in 3, a superinfection developed in 1, and surgical treatment was required in 7 cases—mainly secondary amputation or debridement (Table 1). These side effects were not direct consequences of EST, but are typical complications in this patient population.
Serious adverse events occurred in 5 cases (2 deaths, 1 amputation, 1 hospitalization, 1 allergic reaction), none of which was causally related to the EST.
Results
Patients
Ninety-five patients (68% men) were evaluated by ITT and 45 patients by PV, with a mean age in the ITT population of 69.1 ± 12.6 years. All cases were considered to be refractory to standard wound treatment and had been treated previously for an average of 13.7 months. A majority were vascular wounds (n = 62, 65.3%), followed by diabetic foot ulcers (n = 14, 14.7%), and pressure ulcers (n = 2, 2.1%). The remaining comprised various wounds (n = 14, 17.9%) that were mainly postoperative. The wounds were located overwhelmingly on the lower leg or foot (Figure 2). The mean duration of EST was 48.1 days.
(Enlarge Image)
Figure 2.
Distribution of the wound sites under EST (n = 95).
Wound Status
Granulation and epithelialization increased markedly under EST, which was determined by evaluating the scaled wound photos (Figure 3). The proportion of wounds without granulation decreased from 17% to 0% in the ITT evaluation, and complete granulation was achieved in 30.4% of the wounds. The proportion of wounds with epithelialization increased in the total group from 15.4% to 80.4%. The effects were more apparent in the patients observed throughout the entire study (PV analysis); the number of wounds that re-epithelialized increased in this group from 8.9% to 80% (Figure 3). The mean wound area was 44.7 cm2, which decreased over the course of EST to 24.5 cm2 (Figure 4).
(Enlarge Image)
Figure 3.
Granulation and epithelialization, comparison of all registered patients (n = 95) with patients with a complete data set (n = 45), (ITT vs. PP analysis), scaling 0 = none, 1 = 25%, 2 = 50%, 3 = 75%, 4 = 100%.
T1 = Before treatment
T2 = Follow-up after 2–6 weeks
T3 = Follow-up after 8–12 weeks or treatment discontinuation
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Figure 4.
Figure 4. Mean wound area in cm (all registered patients, n = 95).
T1 = Before treatment
T2 = Follow-up after 2–6 weeks
T3 = Follow-up after 8–12 weeks or treatment discontinuation
Wound Odor
The proportion of patients with wound odor decreased in the total group from 44.0% at T1 to 26.1% at T3 (Figure 5).
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Figure 5.
Proportion of patients with/without wound odor over the course of therapy (all registered patients, n = 95).
T1 = Before treatment
T2 = Follow-up after 2–6 weeks
T3 = Follow-up after 8–12 weeks or treatment discontinuation
Wound Margins
The condition of the wound margins improved under EST and was described as unirritated, reddened, edematous, macerated, reddened and edematous, reddened and macerated, reddened and necrotic, edematous and macerated, or macerated and livid. The proportion of unirritated wound margins increased markedly by a half (48.8%), while that of reddened margins fell by about half (51.9%). Macerations were relatively common with EST therapy, remaining constant at about one-third (T1 27.5%, T2 33,3%, T3 28.5%; Figure 6).
(Enlarge Image)
Figure 6.
Assessment of the wound margins (all registered patients, n = 95). The chart shows the percentage of patients with the respective variable.
T1 = Before treatment
T2 = Follow-up after 2–6 weeks
T3 = Follow-up after 8–12 weeks or treatment discontinuation
Periwound Skin Condition
Periwound condition was assessed on a 10-point scale (unirritated, reddened, edematous, macerated, dry, scaly, reddened and edematous, reddened and macerated, edematous and macerated, edematous and scaly). The proportion of wounds with healthy periwound skin increased from T1 with 20.9% to T3 with 60.9%.
Secretion
Overall, the number of secreting wounds declined from 88% to 70.6%. Above all, however, the amount of exudate decreased, and the proportion of wounds with moderate to profuse exudation decreased from 47.1% to 17.4% (Table 2).
Wound Surface Tissue
The proportion of patients with wound surface fibrin or necrosis decreased markedly from T1 to T3: 85% of the wounds exhibited fibrin or necrosis at T1 compared to 25% at T3. Additionally, the proportion of wounds with no fibrin or necrosis increased from 5.5% to 41.3%.
Wound Pain
Wound-related pain was measured at rest, during exercise (normal daily activities), and during dressing changes. It was greatest during exercise at the start of the observation (T1) with a mean of 4.3; it was 2.4 at rest, and 2.6 during dressing change. Pain intensity decreased markedly on the VAS during EST by an average of 0.9 point at rest, by 2.0 during exercise, and by 0.9 during dressing change (Figure 7).
(Enlarge Image)
Figure 7.
Wound pain at rest, during exercise, and during dressing changes (all registered patients, n = 95). T1 = Before treatment
T2 = Follow-up after 2–6 weeks
T3 = Follow-up after 8–12 weeks or treatment discontinuation
Effectiveness and Tolerability
The global effectiveness of EST was described as "good" or "very good" by 74% of the patients, while the treatment was described as "good" by 48.1% and as "very good" by 29.1% (Figure 8).
A majority of patients were also satisfied with the tolerability of EST, with 78.5% describing it as "good" or "very good" (54.4% and 24.1 %, respectively; Figure 8).
(Enlarge Image)
Figure 8.
Global assessment of the effectiveness and tolerability of electrical stimulation using an ESD (all registered patients, n = 95).
Adverse Events and Side Effects
Adverse events occurred in a total of 38 patients by the end of the study; they included 13 cases of mesh graft or flap graft, which automatically led to their exclusion from the study, although these were not adverse events per se. One or more adverse events were recorded in 37.3% of patients at T2 and in 14.6% at T3. There were 12 patients for whom it was not documented whether adverse events had occurred.
Side effects (ie, adverse events that were directly associated with EST) included skin reactions to the dispersive electrode (n = 4), irritation of the periwound skin (n = 4), and maceration (n = 1). An expert performed a retrospective assessment of whether an association existed between EST and the side effects.
Deterioration of the wound status occurred in 3, a superinfection developed in 1, and surgical treatment was required in 7 cases—mainly secondary amputation or debridement (Table 1). These side effects were not direct consequences of EST, but are typical complications in this patient population.
Serious adverse events occurred in 5 cases (2 deaths, 1 amputation, 1 hospitalization, 1 allergic reaction), none of which was causally related to the EST.
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