Evidence Based Review Franek et al 2004 (Level II) (Dissertation Sample)

EVIDENCE BASED REVIEW
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Evidence Based Review
Franek et al 2004 (Level II)
Franek, (2004) aimed at comparing two different intensities of ultrasound, 1.0 W/cm2 and 0.5 W/cm2, plus compressive therapy, and a third group who received topical pharmacological treatment and compressive therapy. The therapeutic range for the power density of ultrasound is between 0.1 and 3W/cm2.
The objective of the study was to comparatively determine which of the ultrasound power densities between 0.5 W/cm2 and 1W/cm2 was more effective at reducing the volume and area of leg ulceration. The study also made attempts in determining whether and which of the ultrasound densities used had significant impact on the granulation, self-debridement and epithelialization of the wound. This ensures that the different ultrasound causative factors and mechanisms are dominant along the range in various bands. These ranges directly influence the choice of the optimum application and technical parameters of ultrasound employed in enhancing the process of venous ulcers healing.
The study randomly divided the sampled 65 patients with venous ulcers into three groups named: A, B and C. The 22 patients in group A were treated with ultrasound set at 1W/cm2 combined with comprehensive therapy while the 21 patients in group B were subjected to ultrasound set at 0.5W/cm2 combined with comprehensive therapy. The 22 patients in group C, on the other hand, were given topical pharmacological treatment in combination with compressive therapy as well. This treatment was accompanied by local baths of potassium permanganate plus wet dressings of a solution of 0.1 copper sulphate. Compresses of chloramphenicol, gentamicin, fibrolan and colistin were also used. The drugs were administered alternatively after a few days for up to 3 weeks.
The two treatment groups A and B received ultrasound procedure in a water bath with a temperature of 34 degrees Celsius, time depended on wound size. Ultrasound was delivered daily for three weeks. The patients in group A and B were as well administered with topical wet dressings of an isotonic saline media. The group did not receive further phlebotropic or tropical drug treatments. The methods applied compressive therapy for group A and B by removing the dressing during the periods of treatment and reapplying them immediately after the treatment.
The method measured the changes observed in the ulcerated areas through planimetric measurements of the congruent, homothetic projections of these regions with the help of digitizing tablet. The depth of the ulcer was also measured using a precision-built mechanical micrometer.
The study further developed healing rate indicators to help in accurately presenting the progress of the process. The indicators were defined as below;
ωS=δs/tC
where ωS=weekly rate of change of relative ulcer area (% per week)
tC=total treatment time
δS=change of relative ulcer area (in %)
δS=(S1xS2) x100%/S1, where S1=ulcer baseline
area
S2=ulcer final area.
ωV=tC
where ωV=weekly rate of change of relative volume of the ulcers (% per week)
tC=total treatment time
δV=change of relative volume of the ulcers (in %)
δV=(V1xV2) x100%/V1, where V1=ulcer base
line volume
V2=ulcer final volume.
The self-debridement of wounds was represented by the rate of change of suppurate area and by the relative change of the suppurate area in percentages. The relative suppurate area was calculated as follows:
R1=r1/S1 x100%
where R1=relative suppurate area before treatment (in %)
r1=suppurate area before treatment
S1=ulceration area before treatment.
R2=r2/S2x100%
where R2=relative suppurate area after treatment (in %)
r2=suppurate area after treatment
S2=ulceration area after treatment.
The degree of granulation was evaluated by means of the granulation rate indicator and percentage change of granulated area. The relative granulation area was
calculated as follows:
Z1=z1/S1 x100%
where Z1=relative granulation area before treatment (in%)
z1=granulation area before treatment
S1=ulceration area before treatment.
Z2=z2/S2 x100%
where Z2=relative granulation area after treatment (in %)
z2=granulation area after treatment
S2=ulceration area after treatment.
Statistically significant reduction in ulcer area was found in all three groups. The average weekly change was fastest in the treatment group who received ultrasound at 0.5 W/cm2 plus compressive therapy. That application of ultrasound at 1.0 W/cm2 was not more beneficial than traditional methods. The application of ultrasound at 0.5 W/cm2 was found to be equal or better than traditional methods (p≤0.05). The physical findings for patients of various histories are shown in the table below:
Findings

Group A n (%)

Group B n (%)

Group C n (%)

Edema, hyper pigmentation lipodermatosclerosisof ulcerated extremity.

22(100)

21(100)

22(100)

Superficial varicosities of ulcerated extremity

7(32)

10(47.6)

6(27.3)

Previously known deep venous thrombosis in ulcerate d extremity

12(54.5

12(57.1)

6(27.3)

Overweight (BMI> 30 kg/m2)a

12 (55.5)

8(38.1)

5(27.8)

Smokers

6(27.2)

4(19)

4(18.2)

The following data was obtained using the Wilcoxon’s pair sequence test:
Ulceration area before treatment (S1) (cm2)
Average A=15.62 B=15.57 C=23.74
Median A=12.51 B=6.71 C=11.72
Ulceration area after treatment (S2) (cm2)
Average A=14 B=9.29 C=20.58
Median A=11.14 B=3.78 C=9.86
Level of significancea pA=0.0001 pB=0.00006 pC=0.002
Volume of ulceration before treatment (V1) (cm3)
Average A=3.62 B=2.86 C=8.26
Median A=2.63 B=1.74 C=4.13
Volume of ulceration after treatment (V2) (cm3)
Average A=3.06 B=0.77 C=4.87
Median A=1.69 B=0.31 C=1.94
Level of significancea pA=0.0006 pB=0.0002 pC=0.00005
Longest dimension before treatment L1 (cm)
Average A=5.57 B=4.96 C=6.58
Median A=5.3 B=3.6 C=5.4
Longest dimension after treatment L2 (cm)
Average A=5.1 B=3.54 C=5.85
Median A=4.95 B=2.2 C=5
Level of significancea pA=0.0002 pB=0.00006 pC=0.003
Widest dimension before treatment (C1) (cm)
Average A=3.18 B=3.25 C=3.97
Median A=3 B=2 C=3.3
Widest dimension after treatment (C2) (cm)
Average A=2.95 B=1.91 C=3.35
Median A=2.8 B=1.3 C=2.85
Level of significance pA=0.0008 pB=0.00006 pC=0.001
The study crucially analyses the impact of the various ultrasonic intensities on the process of wound healing. This is important in proving the ultrasonic therapy as an effective modality for supporting leg ulcer treatment. The results obtained from the methods used in this study are not consistent with the literature on the use of ultrasound in ulcers treatment. Other methods have effectively employed longer periods and appropriate densities to produce higher VLU healing efficiencies. The weekly maximum weekly ulcer suppurate area reduction rate achieved by the method is at 67.6 percent achieved by the treatment group A. This presents a lower rate compared to the 91 percent reduction rates achieved by Callam et al using pulse wave with a frequency of 1MHz.Dyson et al achieved further high efficiency using 1w/cm2 ultrasound power density with a pulse wave frequency of 3MHz. The method has therefore employed too small a number of the subjects upon which the authors have based their conclusions.
The method employed, however, has demonstrated effectively the importance of different ultrasound power densities in the healing of venous leg ulcers. The method established that ultrasound power density of 0.5W/cm2 is far more effective in producing quick changes in leg ulcers healing compared to a power density of 1W/cm2 as observed for treatment groups B and A respectively.
The study incorporates trials for up to three combinations of the methods under investigation including the various ultrasonic intensities, compressive therapy and pharmacological treatment. Also, the study effectively established the efficiency of the various ultrasound power densities, with 0.5W/cm2 achieving quicker changes than 0.1W/cm2.
The study incorporated too small a number of methodological subjects upon which the conclusions are based. As a result, the literature provided by the study was inconclusive in terms of the results and showed differences relating to the density of the ultrasound power used in ulcer treatment when compared to other efficient studies.
Johannsen et al 1998 (Level I)
The aim of this study was to assess the available evidence concerning the ultrasound therapy in the treatment of chronic leg ulcers. The study carried out research on fourteen articles published since 1950 and based on the keywords ultrasound therapy, healing and chronic leg ulcers. These articles were obtained from Index Medicus and Medline databases. Out of the fourteen studies reviewed, six studies merited the inclusion criteria used for a RCT and presented their data in a manner that made the pooling of information regarding ulcer decrease as a percentage of the starting ulcerated area possible. The study applied a standardized effect size that gave evidence for a significance impact of ultrasound. The information obtained from the selected articles included the following variables and parameters; sample size, sex and age, selection criteria, inclusion and exclusion criteria, number of drop-outs; ulcer etiology ; randomization, comparison group treatment (i .e ., placebo treatment, no treatment, non-ultrasound treatment), cross-over design; blinding of patient, physiotherapist, and evaluator; description of ultrasound apparatus, name of manufacturer, descriptio...