Low-frequency Noncontact Nonthermal Ultra-sound Therapy a Review of the Literature

Groundwork and Purpose

The optimal adjunctive therapy for wounds that fail to heal despite conventional wound care has not been established. Clinical show suggests improved healing in wounds treated with noncontact ultrasound therapy (NCUT). Although existing evidence supports the use of NCUT for enhanced wound healing, the full number of participants studied remains modest. This study was conducted to assess the impact of adjunctive NCUT on the healing of wounds that neglect to progress to healing with conventional wound care solitary.

Participants and Methods

A retrospective review of charts for 76 patients who had received outpatient wound care at a single center betwixt Jan 2005 and December 2006 and who were treated with NCUT as an adjunct to conventional wound care was conducted. All wound care interventions used during the written report period were assessed. The principal effectiveness endpoint was the percent of change in wound surface area from the first of NCUT to the end of NCUT.

Results

Noncontact ultrasound was administered for a mean of v.1 minutes per session for a mean of 2.iii times per week. The median duration of therapy was 4.3 weeks. The median wound area was reduced by 79% from the start of NCUT to the terminate of NCUT (from ii.5 to 0.6 cmⁱⁱ). The proportion of participants with greater than 75% granulation tissue increased from 32% before NCUT to 46% subsequently NCUT.

Give-and-take and Determination

The single-arm, retrospective design did not allow for comparative assessments of the efficacies of noncontact ultrasound and other wound care interventions. The use of adjunctive NCUT appears to improve healing in wounds that fail to heal with conventional wound intendance alone.

Traditional wound healing interventions (eg, optimized nutritional condition; debridement to remove devitalized tissue; moist dressings to maintain a clean, moist bed of granulation tissue; compression; and handling to resolve infection) often succeed in promoting wound closure in a reasonable time.one For wounds that fail to heal despite the administration of conventional wound care, clinicians are challenged to determine the optimal handling to augment conventional therapy. Even with blazon-specific intendance, such every bit frequent repositioning for pressure ulcers, off-loading of pressure level and good glucose control for diabetic ulcers, and compression systems for venous ulcers, some wounds still fail to heal.

Wound healing modalities offer a potential solution for closing nonhealing wounds. Electrical stimulation, pulsed electromagnetic induction, negative-pressure wound therapy, and high-frequency (megahertz) pulsed-electric current ultrasound have all contributed in healing chronic wounds.ane Noncontact, low-frequency ultrasound is among the newer modalities available to enhance the healing of chronic wounds. Although high-frequency ultrasound (ane–3 MHz) has been used in clinical practice in physical therapy, physical medicine, rehabilitation, and sports medicine for many years, noncontact ultrasound therapy (NCUT) operating at a markedly lower frequency (forty kHz) has been approved for use in the wound care setting for simply about 3 years.two

In recent years, clinical evidence of improved healing of chronic wounds treated with NCUT has been accumulating. Ii prospective randomized studies demonstrated greater wound healing at 12 weeks when conventional therapy was augmented with NCUT. In a randomized study of 70 patients with chronic disquisitional limb ischemia (transcutaneous oximetry value of ≤xl mm Hg), 63% of patients treated with noncontact ultrasound in addition to conventional wound intendance showed greater than 50% wound healing at 12 weeks, whereas 29% of patients receiving conventional wound care alone (control patients) showed this level of healing (P<.001).iii Ennis et al4 conducted a double-blind, sham-controlled trial of 55 patients receiving conventional wound intendance for recalcitrant diabetic foot ulcers. In that study, 41% of patients treated with noncontact ultrasound healed in 12 weeks, whereas 14% of patients treated with a sham process healed in that time period (P=.04).4 In addition, 2 prospective nonrandomized studies did not include control groups. For 51 patients with lower-extremity wounds of various etiologies, Kavros and Schenck5 observed reductions in healing time (9.8 weeks versus 5.5 weeks, P<.0001) and percentage of wound volume (37% versus 95%, P<.0001) when NCUT was added to conventional wound care. A hateful healing time of 7 weeks in 23 patients treated with noncontact ultrasound and conventional wound intendance was statistically meaning compared with a hateful healing fourth dimension of 10 weeks reported for a historical control grouping treated with conventional wound care lone (P=.0005).vi

Although the evidence supporting NCUT appears to exist fairly positive, the total number of participants studied remains modest. An evaluation of more than participants is needed to firmly constitute the benefit of this novel therapy. The present study was undertaken at the Eye for Advanced Wound Care, St Joseph's Medical Centre, Reading, Pennsylvania, to assess the touch of adjunctive NCUT on the healing of wounds that fail to progress to healing with conventional wound care.

Method

Study Population

We conducted a retrospective review of charts for patients who had received outpatient wound intendance at our middle from January 2005 to December 2006 and who were treated with NCUT as an offshoot to conventional wound intendance.

All participants who were treated with noncontact ultrasound during the written report menstruum and who met the entrance criteria were considered for this analysis. Eligible participants were aged eighteen years or older, had a nonhealing wound of any etiology, and received NCUT of the wound at least 2 times per week during the written report menses. Nonhealing wounds were those that had failed to progress to at least fifteen% closure in the prior 2 weeks of therapy. Clinicians trained in the utilize of NCUT selected wounds on the basis of the need for cleansing and debridement. At the time of treatment, the clinicians were not aware that these data would be nerveless for a retrospective study.

Participants were excluded from this analysis if therapy was provided fewer than 2 times per week, their life expectancy was less than 6 months, or NCUT was contraindicated. Noncontact ultrasound therapy is contraindicated when an electronic implant or prosthesis is located near the treatment site (eg, near or over the centre or thoracic area in a participant with a cardiac pacemaker) or the handling site is on the lower back during pregnancy, over the uterus during pregnancy, or over an area of malignancy.7

Before the outset of this written report, participants included in this assay signed a general consent grade authorizing review of their medical records for research purposes. An additional consent form for this analysis was not required. Investigative site personnel confirmed the presence of a signed general research consent course for all participants included in this study.

Study Treatments

Data on all wound care interventions used during the study catamenia, including conventional wound care and NCUT, were assessed. Conventional wound care at our center consists of moist wound dressings, selective debridement of debilitated tissue, pneumatic sequential pinch and compressive wrapping for edema reduction, and other biophysical technologies indicated for the wound characteristics or associated symptoms.

For NCUT, handling time per session is dependent on the full ulcer area. In general, treatment time increases equally total ulcer area increases. The manufacturer's treatment algorithm for the NCUT organization covers ulcer areas from less than 10 cm² to 180 cm², with handling times ranging from iii to 20 minutes.vii The noncontact ultrasound device delivers low-frequency (40-kHz) ultrasound to the ulcer bed through a fine, sterile saline mist without directly contact of the ultrasound transducer with the torso.2 The mist generated by the system is of relatively uniform particle size and acts as a conduit for transmitting ultrasound free energy. The United states Food and Drug Administration has identified the device as a low-energy ultrasound wound cleaner that "produces a low-free energy ultrasound-generated mist used to promote wound healing through wound cleansing and maintenance debridement by the removal of yellowish slough, fibrin, tissue exudates and bacteria."8

Data Collection

The following baseline parameters were collected: medical history (including comorbidities), physical examination (meridian, weight, and vital signs), appropriate laboratory and imaging studies (including the ankle-brachial alphabetize), history and etiology of the treated wound, wound measurements and characteristics, and participant-reported hurting rating with a numeric rating calibration, if available. All treatments used during the study catamenia were recorded. For NCUT, data collection included time, frequency, and duration of treatments (eg, 5-infinitesimal treatments three times per week for vi weeks); total number of treatments; and agin events related to devices, therapy, or both. Information on wound sizes, wound characteristics, and numeric pain ratings at the completion of NCUT were collected.

Study Assessments

The main effectiveness endpoint was the pct of change in wound expanse from the start of NCUT to the end of NCUT. Wound expanse was measured as the greatest length times the greatest width perpendicular to the length or past use of a caput-to-toe anatomical orientation measuring the length from 12 o'clock to 6 o'clock and the perpendicular width from three o'clock to 9 o'clock. The percentage change in wound area from the beginning of NCUT to the end of NCUT was calculated as follows: [(showtime expanse – end area)/(showtime expanse)] × 100. The primary safe endpoint was the proportion of participants experiencing treatment-related adverse events during the study period. Secondary endpoints included changes in amounts of exudate and debilitated tissue from the beginning of NCUT to the finish of NCUT.

Information Analysis

This retrospective study population consisted of participants treated with adjunctive NCUT between January 2005 and December 2006. Upwards to 100 participants could be reviewed against the entrance criteria to determine eligibility. Formal power calculations to determine sample size were non performed. The master endpoint was the percent of alter in wound area. 4 normality tests (Shapiro-Wilks test, P<.0001; Kolmogorov-Smirnov test, P<.0100; Cramer-von Mises test, P<.0050; and Anderson-Darling examination, P<.0050) indicated meaning departure from the normality supposition. Additionally, a visual inspection of the histogram of values for the percent of reduction in wound area and a normal quantile plot of the values confirmed a significant skewed distribution. Therefore, the Wilcoxon signed rank test was used to make up one's mind significance.

Other statistical comparisons were performed to assess corroboration with the primary endpoint. Descriptive statistics were used to describe the participants and their wounds at the first of NCUT and the stop of NCUT. Paired comparisons of data at baseline and at the terminate of treatment were made with the Wilcoxon signed rank exam for continuous variables and the McNemar examination for categorical variables. Statistical analyses were performed with SAS, version 9.one.3.*

Office of the Funding Source

Statistical and writing back up was funded past Celleration Inc. The authors written report no financial interest in Celleration Inc and received no funding or compensation for the study or their time spent writing the article.

Results

Participant Characteristics

Between January 2005 and December 2006, 76 participants coming together the study eligibility criteria were treated with NCUT in addition to conventional wound care. As shown in Table 1, participants in this study were predominantly white, with a hateful age of 62 years and a slightly higher proportion of men than of women. As is frequently the example in chronic wound care, comorbid medical conditions were the rule rather than the exception. By far, the most mutual comorbid condition was cardiovascular or vascular disorder (91% of participants). Disorders of the integumentary and musculoskeletal systems also were present in nigh of the participants. Twoscore-ii percent of participants had diabetes mellitus.

Table one

Demographic Characteristics of 76 Participants at the Start of Noncontact Ultrasound Therapy

Feature	Value a
Male	55 (42)
Mean age, y (range)	62 (23–96)
Race
Black/African American	7 (5)
White	91 (69)
Hispanic/Latino	iii (2)
Smoking (current)	twenty (15)
Cardiovascular or vascular disorder	91 (68)
Hematologic disorder	42 (32)
Neurological or psychological disorder	xx (15)
Pulmonary disease	24 (18)
Diabetes	42 (32)
Gastrointestinal disorder	16 (12)
Musculoskeletal disorder	60 (45)
Integumentary disorder	75 (57)
Cancer	23 (17)

Characteristic	Value a
Male	55 (42)
Mean age, y (range)	62 (23–96)
Race
Black/African American	seven (5)
White	91 (69)
Hispanic/Latino	iii (2)
Smoking (current)	20 (15)
Cardiovascular or vascular disorder	91 (68)
Hematologic disorder	42 (32)
Neurological or psychological disorder	20 (15)
Pulmonary illness	24 (eighteen)
Diabetes	42 (32)
Gastrointestinal disorder	xvi (12)
Musculoskeletal disorder	60 (45)
Integumentary disorder	75 (57)
Cancer	23 (17)

^a

Reported as percentage (number) of participants, unless otherwise indicated.

Table 1

Demographic Characteristics of 76 Participants at the Start of Noncontact Ultrasound Therapy

Feature	Value a
Male person	55 (42)
Mean historic period, y (range)	62 (23–96)
Race
Black/African American	7 (5)
White	91 (69)
Hispanic/Latino	3 (2)
Smoking (electric current)	20 (15)
Cardiovascular or vascular disorder	91 (68)
Hematologic disorder	42 (32)
Neurological or psychological disorder	20 (15)
Pulmonary affliction	24 (xviii)
Diabetes	42 (32)
Gastrointestinal disorder	16 (12)
Musculoskeletal disorder	threescore (45)
Integumentary disorder	75 (57)
Cancer	23 (17)

Characteristic	Value a
Male	55 (42)
Mean age, y (range)	62 (23–96)
Race
Black/African American	7 (5)
White	91 (69)
Hispanic/Latino	three (2)
Smoking (current)	xx (xv)
Cardiovascular or vascular disorder	91 (68)
Hematologic disorder	42 (32)
Neurological or psychological disorder	20 (15)
Pulmonary disease	24 (18)
Diabetes	42 (32)
Gastrointestinal disorder	16 (12)
Musculoskeletal disorder	lx (45)
Integumentary disorder	75 (57)
Cancer	23 (17)

^a

Reported every bit percentage (number) of participants, unless otherwise indicated.

Wound Characteristics

Wound characteristics at the showtime of this study are shown in Table two. Most of the wounds were located on the lower extremities. Approximately one third of the wounds resulted from venous insufficiency. The origins of the remaining two thirds of the wounds were related to force per unit area, surgery, and trauma. Infection was non present in any wounds in this study. Wounds in this study had been present for a median of viii weeks, although the range was broad, spanning from 2 to 332 weeks.

Table two

Wound Characteristics at the First of Noncontact Ultrasound Therapy for 76 Participants

Wound Characteristic	Value
Duration, wk
Mean/median	20.9/eight.0
SD	44.8
Range	2–332
Area, cm2
Mean/median	eight.2/2.5
SD	14.8
Range	0.1–96.0
Location, % (no.)
Sacrum	1 (i)
Leg	68 (52)
Heel	3 (ii)
Pes a	20 (15)
Other b	8 (6)
Etiology, % (no.)
Pressure	4 (3)
Venous insufficiency	37 (28)
Arterial insufficiency	4 (3)
Surgery	13 (10)
Trauma	20 (15)
Other c	22 (17)

Wound Feature	Value
Elapsing, wk
Mean/median	xx.9/eight.0
SD	44.8
Range	2–332
Area, cmii
Mean/median	8.2/2.5
SD	14.8
Range	0.1–96.0
Location, % (no.)
Sacrum	1 (i)
Leg	68 (52)
Heel	iii (2)
Foot a	twenty (15)
Other b	viii (6)
Etiology, % (no.)
Pressure	4 (3)
Venous insufficiency	37 (28)
Arterial insufficiency	four (3)
Surgery	13 (10)
Trauma	xx (xv)
Other c	22 (17)

^a

Includes 6 diabetic human foot ulcers.

^b

Other locations: amputation below the knee (four), belly (1), and back (i).

^c

Other etiologies: diabetic foot ulcers (6), burns (2), spider bites (iii), vasculitis (ii), bullous pemphigus (1), warfarin necrosis (i), edema (1), and necrobiosis lipoidica (1).

Tabular array ii

Wound Characteristics at the Start of Noncontact Ultrasound Therapy for 76 Participants

Wound Feature	Value
Elapsing, wk
Mean/median	xx.9/8.0
SD	44.8
Range	2–332
Area, cm2
Mean/median	8.two/2.5
SD	14.viii
Range	0.i–96.0
Location, % (no.)
Sacrum	1 (1)
Leg	68 (52)
Heel	3 (2)
Foot a	twenty (fifteen)
Other b	8 (half dozen)
Etiology, % (no.)
Pressure level	4 (3)
Venous insufficiency	37 (28)
Arterial insufficiency	iv (3)
Surgery	13 (10)
Trauma	xx (15)
Other c	22 (17)

Wound Characteristic	Value
Duration, wk
Hateful/median	xx.9/viii.0
SD	44.8
Range	2–332
Expanse, cm2
Mean/median	8.two/2.v
SD	xiv.viii
Range	0.1–96.0
Location, % (no.)
Sacrum	1 (1)
Leg	68 (52)
Heel	3 (2)
Foot a	xx (15)
Other b	viii (6)
Etiology, % (no.)
Force per unit area	iv (3)
Venous insufficiency	37 (28)
Arterial insufficiency	4 (3)
Surgery	xiii (ten)
Trauma	20 (15)
Other c	22 (17)

^a

Includes 6 diabetic foot ulcers.

^b

Other locations: amputation below the human knee (iv), belly (i), and back (1).

^c

Other etiologies: diabetic pes ulcers (6), burns (2), spider bites (iii), vasculitis (2), bullous pemphigus (1), warfarin necrosis (1), edema (1), and necrobiosis lipoidica (i).

The marked deviation between the mean (8.2 cmⁱⁱ) and the median (two.5 cm^two) values for wound area reflects a distribution skewed by a few large wounds. In such a population, median values provide the more representative moving-picture show of wound size over time. Wound volume in our written report population could not be calculated considering of the inability to assess wound depth for both necrotic wounds (for which depth measurements cannot be obtained) and partial-thickness wounds (routinely classified at our center equally <0.1 cm and interpreted as 0 in database analysis).

Handling Characteristics

On average, participants received NCUT for a mean of five.1 (range=iii.0–10.4) minutes per session for a hateful of 2.3 (range=1.5–4.0) times per calendar week. The median duration of NCUT over the course of the report period was 4.3 weeks, although the range of handling durations was broad (0.9–21.7 weeks). For the 13 wounds (eighteen%) that airtight completely during the study menses (Tab. 3), the median time to closure was 3.6 weeks. The relatively curt duration of NCUT, given that only xviii% of wounds healed completely, reflects the use of this modality for a cleansing and debridement indication (ie, until slough is removed and the development of healthy granulation tissue is axiomatic).

Table 3

Wound Characteristics at the Start of Noncontact Ultrasound Therapy (NCUT) vs the End of NCUT

Characteristic	% (no.) at:		P a
	Baseline	Terminate of Treatment
Skin around wound			<.0001 b
Normal	20 (15)	76 (58)
Irritated	3 (2)	iv (iii)
Erythematous	21 (16)	3 (two)
Edematous	41 (31)	4 (3)
Calloused	8 (6)	4 (three)
Other	26 (20) c	9 (7) d
Undermining	1 (1)	0 (0)	.3173
Tunneling	0 (0)	0 (0)	NA eastward
Odor	1 (one)	0 (0)	.3173
Maceration			.0082
None	91 (67)	100 (76)
Minimal	viii (6)	0 (0)
Moderate	1 (1)	0 (0)
Maximum	0 (0)	0 (0)
Corporeality of exudate			.0002
None	iii (two)	34 (24)
Scant	35 (26)	39 (28)
Moderate	53 (39)	21 (15)
Maximum	9 (7)	half-dozen (4)
Type of exudate			.7127
Sanguineous	13 (ix)	17 (8)
Serous	76 (54)	79 (37)
Serosanguineous	four (3)	4 (two)
Purulent	vii (v)	0 (0)
Corporeality of healthy granulation tissue			.0001 f
Complete closure	0 (0)	xviii (xiii)
76%–99%	32 (24)	46 (34)
51%–75%	7 (5)	4 (3)
26%–50%	28 (21)	15 (11)
ane%–25%	22 (17)	eleven (eight)
None	12 (9)	7 (five)
Corporeality of eschar			.1573
None	97 (73)	100 (75)
<l%	3 (2)	0 (0)
Amount of fibrin slough			.0116
None	27 (nineteen)	55 (41)
<50%	18 (thirteen)	13 (x)
≥50%	55 (39)	32 (24)

Characteristic	% (no.) at:		P a
	Baseline	Finish of Treatment
Peel around wound			<.0001 b
Normal	20 (15)	76 (58)
Irritated	3 (2)	four (iii)
Erythematous	21 (16)	3 (2)
Edematous	41 (31)	iv (iii)
Calloused	viii (6)	iv (iii)
Other	26 (20) c	nine (seven) d
Undermining	one (1)	0 (0)	.3173
Tunneling	0 (0)	0 (0)	NA e
Olfactory property	1 (one)	0 (0)	.3173
Maceration			.0082
None	91 (67)	100 (76)
Minimal	8 (vi)	0 (0)
Moderate	1 (ane)	0 (0)
Maximum	0 (0)	0 (0)
Amount of exudate			.0002
None	three (2)	34 (24)
Scant	35 (26)	39 (28)
Moderate	53 (39)	21 (xv)
Maximum	9 (7)	half dozen (four)
Type of exudate			.7127
Sanguineous	xiii (9)	17 (viii)
Serous	76 (54)	79 (37)
Serosanguineous	4 (three)	4 (2)
Purulent	7 (v)	0 (0)
Amount of healthy granulation tissue			.0001 f
Complete closure	0 (0)	18 (thirteen)
76%–99%	32 (24)	46 (34)
51%–75%	vii (5)	four (iii)
26%–50%	28 (21)	fifteen (11)
ane%–25%	22 (17)	11 (8)
None	12 (nine)	7 (5)
Amount of eschar			.1573
None	97 (73)	100 (75)
<l%	3 (2)	0 (0)
Corporeality of fibrin slough			.0116
None	27 (19)	55 (41)
<50%	18 (13)	xiii (x)
≥50%	55 (39)	32 (24)

^a

As determined with the McNemar test.

^b

P value for comparison of percent of normal pare effectually wound at first of treatment vs end of handling.

^c

Other=indurated (xi), inflamed (3), cyanotic (2), bruised (1), ecchymotic (1), excoriated (one), and hyperpigmented (1).

^d

Other=indurated (6) and hyperpigmented (one).

^eastward

NA=not applicable.

^f

P value for comparison of start logos75% granulation tissue at start of handling vs stop of treatment.

Table 3

Wound Characteristics at the Start of Noncontact Ultrasound Therapy (NCUT) vs the End of NCUT

Characteristic	% (no.) at:		P a
	Baseline	End of Treatment
Skin around wound			<.0001 b
Normal	20 (xv)	76 (58)
Irritated	three (ii)	4 (3)
Erythematous	21 (16)	3 (2)
Edematous	41 (31)	iv (3)
Calloused	8 (6)	4 (3)
Other	26 (xx) c	9 (7) d
Undermining	1 (one)	0 (0)	.3173
Tunneling	0 (0)	0 (0)	NA due east
Olfactory property	1 (1)	0 (0)	.3173
Maceration			.0082
None	91 (67)	100 (76)
Minimal	8 (half dozen)	0 (0)
Moderate	1 (1)	0 (0)
Maximum	0 (0)	0 (0)
Amount of exudate			.0002
None	three (2)	34 (24)
Scant	35 (26)	39 (28)
Moderate	53 (39)	21 (15)
Maximum	9 (7)	6 (4)
Type of exudate			.7127
Sanguineous	13 (ix)	17 (eight)
Serous	76 (54)	79 (37)
Serosanguineous	four (3)	4 (2)
Purulent	7 (5)	0 (0)
Amount of salubrious granulation tissue			.0001 f
Complete closure	0 (0)	xviii (13)
76%–99%	32 (24)	46 (34)
51%–75%	7 (5)	4 (three)
26%–50%	28 (21)	fifteen (eleven)
1%–25%	22 (17)	11 (8)
None	12 (9)	vii (5)
Amount of eschar			.1573
None	97 (73)	100 (75)
<50%	3 (2)	0 (0)
Corporeality of fibrin slough			.0116
None	27 (19)	55 (41)
<50%	xviii (xiii)	13 (10)
≥50%	55 (39)	32 (24)

Feature	% (no.) at:		P a
	Baseline	Finish of Handling
Skin around wound			<.0001 b
Normal	20 (15)	76 (58)
Irritated	3 (2)	4 (iii)
Erythematous	21 (sixteen)	3 (2)
Edematous	41 (31)	4 (3)
Calloused	8 (six)	4 (3)
Other	26 (xx) c	9 (7) d
Undermining	1 (ane)	0 (0)	.3173
Tunneling	0 (0)	0 (0)	NA e
Odour	ane (1)	0 (0)	.3173
Maceration			.0082
None	91 (67)	100 (76)
Minimal	8 (6)	0 (0)
Moderate	1 (1)	0 (0)
Maximum	0 (0)	0 (0)
Amount of exudate			.0002
None	iii (two)	34 (24)
Scant	35 (26)	39 (28)
Moderate	53 (39)	21 (xv)
Maximum	ix (7)	6 (4)
Type of exudate			.7127
Sanguineous	13 (ix)	17 (8)
Serous	76 (54)	79 (37)
Serosanguineous	iv (iii)	4 (2)
Purulent	7 (5)	0 (0)
Amount of healthy granulation tissue			.0001 f
Complete closure	0 (0)	xviii (13)
76%–99%	32 (24)	46 (34)
51%–75%	seven (5)	4 (iii)
26%–50%	28 (21)	15 (11)
1%–25%	22 (17)	11 (viii)
None	12 (ix)	seven (5)
Amount of eschar			.1573
None	97 (73)	100 (75)
<50%	3 (2)	0 (0)
Amount of fibrin slough			.0116
None	27 (xix)	55 (41)
<50%	18 (13)	xiii (10)
≥fifty%	55 (39)	32 (24)

^a

As determined with the McNemar exam.

^b

P value for comparing of percentage of normal skin around wound at start of treatment vs stop of handling.

^c

Other=indurated (11), inflamed (3), cyanotic (2), bruised (1), ecchymotic (i), excoriated (1), and hyperpigmented (one).

^d

Other=indurated (6) and hyperpigmented (1).

^{due east}

NA=not applicable.

^f

P value for comparing of start logos75% granulation tissue at start of treatment vs stop of handling.

Wound Healing Outcomes

Wound surface area information were bachelor for all 76 participants at both the get-go and the end of NCUT. As shown in the Figure, median wound area was reduced by 79% from the start of NCUT to the end of NCUT (P<.0001).

Figure

Changes in median wound surface area from the offset of noncontact ultrasound therapy (NCUT) to the end of NCUT. P values from Wilcoxon signed rank test.

Figure

Changes in median wound area from the get-go of noncontact ultrasound therapy (NCUT) to the end of NCUT. P values from Wilcoxon signed rank test.

Several changes in wound tissue characteristics and drainage suggested a clinical do good of NCUT (Tabular array iii). Outset, the proportion of participants with greater than 75% salubrious granulation tissue rose significantly, from 32% before NCUT to 46% subsequently NCUT (P<.0001). Second, the proportion of pare around the wound rated as normal increased from twenty% before NCUT to greater than 75% after NCUT (P<.0001). Tertiary, the proportion of participants with no fibrin slough increased from 27% to 55% (P=.0116). Fourth, the amount of exudate was reduced significantly. Well-nigh of the wounds (88%) had either moderate or scant drainage at the beginning of NCUT, whereas by the end of treatment, most of the wounds (73%) were classified every bit having either scant or no drainage (P=.0002).

The blazon of exudate (primarily serous) did not change substantially during the study period. Pretreatment eschar was nowadays only in 2 wounds and was not present after the course of treatment with noncontact ultrasound. Undermining, tunneling, odor, and maceration were uncommon, although any corporeality present earlier ultrasound treatment was eliminated after the course of treatment.

Subgroup Analyses

The largest wound type subgroups were venous insufficiency leg wounds (northward=28) and combined traumatic and surgical wounds (north=25). Median treatment durations (three.viii and 4.iv weeks, respectively), mean handling frequency (2.iii times per week), and mean treatment times (five.two and 5.ane minutes, respectively) were similar to those reported for the study population equally a whole. Median wound duration before NCUT, withal, was slightly longer for venous insufficiency wounds (12 weeks, range=2–156) and traumatic or surgical wounds (8 weeks, range=2–332). Every bit shown in the Figure, wound surface area reductions for venous insufficiency wounds (80%, P<.0001) and traumatic or surgical wounds (76%, P=.0002) were comparable to those observed for the written report population as a whole. However, traumatic or surgical wounds tended to be larger both before and after NCUT.

Agin Events

The only adverse consequence reported in this report, a rash, was classified as a nonserious adverse event and was determined to be unrelated to the study treatments. The rash was assessed by the medical director of our center and was adamant to be a reaction to the primary dressing. Symptoms were alleviated through the use of a different dressing.

Pain Ratings

Considering in that location have been reports of reduced wound hurting in participants receiving NCUT,8 we analyzed the change in pain ratings afterwards the starting time of NCUT in this study. Numeric pain ratings were available for 56 participants (74%) at the initiation of ultrasound treatment and 32 participants (42%) at the end of the class of ultrasound treatment. In paired analyses of the 26 participants for whom numeric hurting ratings were bachelor at both the start and the cease of ultrasound treatment, the mean hurting rating was reduced by 1.viii points (P=.0010).

Discussion

In this retrospective analysis, wound surface area decreased by 79% with the improver of a median of 4.3 weeks of NCUT to conventional wound intendance at our center. This reduction in wound size was accompanied past concomitant increases in the amounts of healthy granulation tissue and normal skin around the wound. Furthermore, the amounts of exudate and fibrin slough—characteristics associated with delayed wound healing—decreased significantly during the form of NCUT.

Although retrospective in nature, this analysis contributes data for a comparatively large number of participants treated with noncontact ultrasound to the published trunk of smaller, prospective studies supporting the utility of NCUT in the treatment of nonhealing wounds. Iv prospective studies demonstrated either faster healing times or greater proportions of wounds healed with NCUT than with conventional wound care. Comparison NCUT with a baseline period of conventional wound intendance for 51 participants, Kavros and Schenck5 reported a statistically meaning 44% reduction in treatment time associated with NCUT. Ennis et al6 observed a statistically significant 30% reduction in hateful healing time for chronic lower-extremity wounds of diverse etiologies treated with noncontact ultrasound in a comparison with a historical control group treated with conventional wound care. In a sham-controlled study of 55 patients with diabetic foot ulcers, xl% more than wounds treated with noncontact ultrasound healed completely past 12 weeks.4 In a randomized study of 70 patients with chronic critical limb ischemia, 54% more wounds treated with noncontact ultrasound showed greater than 50% closure in 12 weeks.iii In the present study, the benefit of 75% to fourscore% wound expanse reduction was reported for the overall study population and for the subgroups of participants with venous insufficiency leg wounds (n=28) and wounds of traumatic or surgical origin (north=25).

Although anecdotal reports of pain relief associated with noncontact ultrasound are numerous, this is merely the 2nd study to document decreased wound pain afterwards the initiation of noncontact ultrasound for painful wounds. Gehling and Samies9 retrospectively analyzed the records of 15 consecutive patients who had lower-extremity wounds and received NCUT for 2 to iv weeks. They noted a statistically significant 80% reduction in patient-reported visual analog scale pain scores.9 Although small-scale, our study population was treated at a facility at which numeric hurting ratings are routinely nerveless at the commencement of every visit for wound intendance. Despite the absence of consistent numeric pain ratings in our assay, we did find a statistically pregnant hurting reduction of 1.eight points in the 26 participants with numeric hurting ratings at both the starting time and the end of NCUT. The potential for a palliative benefit of NCUT for painful wounds appears to warrant prospective investigation. Perhaps such a benefit could exist achieved past using noncontact ultrasound as a painless alternative to other debridement therapies known to exacerbate wound hurting (ie, pulsed lavage or sharp debridement).

The wound area reduction observed later on a median of 4.three weeks of NCUT must be considered in the context of the inherent limitations of the present study. Because of the single-arm, retrospective design, nosotros were not able to directly compare the efficacies of noncontact ultrasound and other wound care interventions. Furthermore, the observation that only 18% of wounds in the nowadays study had healed completely past the end of NCUT raises questions about the optimal treatment duration for this therapy. It is clear that noncontact ultrasound was discontinued before wound closure was achieved. Given its indications for wound healing and maintenance debridement, noncontact ultrasound may well be needed merely until slough has been removed and healthy granulation tissue predominates in the wound bed.

Conclusion

Taken together with the prospective testify of improved healing with noncontact ultrasound, the present study provides additional back up for the clinical utility of adjunctive NCUT in promoting the healing of nonhealing wounds of various etiologies.

Ms Bell and Dr Cavorsi provided writing, participants, and facilities/equipment.

The authors thank Teresa Nelson, MS (Technomics Research, LLC), for statistical support and Laurie LaRusso, MS, ELS (Chestnut Medical Communications), for writing back up in the grooming of the manuscript.

The study protocol was canonical by the St Joseph's Hospital Institutional Review Board.

Statistical and writing support was funded by Celleration Inc. The authors report no financial involvement in Celleration Inc and received no funding or bounty for the study or their time spent writing the article.

*

SAS Found Inc, PO Box 8000, Cary, NC 27511.

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© 2008 American Physical Therapy Clan

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Source: https://academic.oup.com/ptj/article/88/12/1517/2742201