APPLICATION OF THE METHOD OF ULTRASOUND CAVITATIONS IN THE COMBINED TREATMENT OF TROPHIC ULCERS OF THE LOWER EXTREMITIES AGAINST THE BACKGROUND OF CHRONIC VENOUS INSUFFICIENCY Soluyanov M.Yu., Shumkov O.A., Smagin M.A., Nimaev V.V.
Research Institute of Clinical and Experimental Lymphology – Branch of Institute of Cytology and Genetics, Novosibirsk, Russia
Trophic ulcers of the lower extremities are identified in 4-5 patients per 1,000 of population [1], achieving 1-1.5 % in the developed countries. There is a persistent trend to increase of the group of such patients. The complications, which are related to progression of chronic venous failure, appear in the quarter of patients with varicose disease and in more than 80 % of patients with postthrombotic disease [2]. Development of trophic ulcers is associated with disorder of local hemolymphocirculation and lesion of microvascular level at the background of various diseases [3]. There are some surgical techniques for correction of venous refluxes, which make the basis of phlebohypertension and trophic ulcer. Considering the low efficiency of conservative methods, it is effectually to use the combined approach with adequate sanitation of the wound defect with use of antiseptics, interactive dressings and physical modalities. It is the pathogenetically substantiated approach [4, 5]. The research and implementation of techniques for treatment of trophic ulcers is important for modern surgical practice.
Objective – to estimate the clinical efficacy of ultrasound cavitations of wounds in the complex treatment of patients with trophic ulcers of the lower extremities and chronic venous insufficiency.
MATERIALS AND METHODS
A clinical study of chronic venous insufficiency of 6th stage (CEAP classification) (Fig. 1) included 90 patients treated in the surgery unit of Research Institute of Clinical and Experimental Lymphology – Branch of Institute of Cytology and Genetics. All patients were randomized into two groups (the main group and the controls). All patients gave their written consent for participation in the study. The informed consent and the clinical study protocol were approved by the local ethical committee.
Figure 1
Trophic ulcers of the right leg before treatment
The control group (50 persons) received the standard surgical techniques for correction of venous reflux: combined subcutaneous phlebectomy with Müller’s miniphlebectomy, and local surgical preparation of the wound defect. The fibrin deposits and soft tissue necrosis were removed with use of the standard surgical procedures.
As addition to the combined subcutaneous phlebectomy and Müller’s miniphlebectomy, the patients of the main group (40 persons) received the course of ultrasonic cavitation of the wound defect with Sonoca 300 (Zoring) with 0.9 % sodium chloride as the medium for ultrasonic cavitation. The procedure was conducted under local anesthesia with 0.75 % ropivacaine. The mean time of manipulation was 3 ± 1 minute. The treatment course included 3 procedures with intervals of 1-2 days. The local treatment of trophic ulcers was conducted with use of wound atraumatic coverings in both groups. The figure 2 shows the appearance of the wounds after combined phlebectomy and the course of ultrasonic cavitation.
Figure 2
Right leg wounds after phlebectomy and 3 procedures of ultrasound cavitation
All patients received the complex of examinations according to the protocol of the clinical examination. The estimation included such parameters of the wound process as time of disappearance of necrosis and fibrin, formation of granulation tissue and boundary and focal epithelialization, and time course of ulcer healing. The analysis of the impression smears of the wounds was conducted after admission on the days 14, 21 and 28.
After examining the normalcy of distribution with use of Kolmogorov-Smirnov test, the data was prepared with the parametric methods for data analysis with use of SPSS. The quantitative data was presented as the mean (M) ± standard deviation (σ). The differences were statistically significant with p < 0.05.
RESULTS
The analysis of the impression smears at the moment of hospital admission showed the predominance of the necrotic type of the cytogram (61.2 ± 3.4 %) over the degenerative inflammatory type (31 ± 3.7 %) in both groups of patients in absence of differences between control and main groups. On the 7th day, the necrotic type was in 3 ± 0.4 % of cases in the control group. It was absent in the main group. Moreover, as compared to the main group, the control group had more cytograms of the degenerative-inflammatory and inflammatory types (13.3 % and 4.3 % correspondingly). The inflammatory-regenerative type was only in the main group (12.5 % and 1.3 % correspondingly). The cytograms of the regeneration type were absent in both groups. The subsequent follow-up did not find any cytograms of the degenerative-inflammation type on the day 14 and found 18.6 ± 1.8 % in the control group. In the main group, the number of cytograms of the inflammation type decreased to 19.9 ± 4.4 % with increasing incidence of the inflammation-regeneration type to 61.4 ± 5.4 % and of the regeneration type to 18.6 ± 1.2 %. Conversely, the control group showed the increase in the incidence of cytograms of the inflammation type to 60.2 ± 5.1 %. The inflammation-regeneration type was found in 21.1 ± 2.9 % of cases. The cytograms of the regeneration type were absent in the control group. It is interesting that the study group showed only the cytograms of the regeneration and inflammation-regeneration types (89.4 ± 6.3 % and 10.6 ± 1.4 cases correspondingly).
The rate of the decrease in the wound size was higher in the main group than in the control one (6.7 ± 0.12 % per day vs. 4.7 ± 0.5 % per day). The differences persisted at all stages of the follow-up. One should note that the rate of decrease of trophic ulcers was minimal on the day 7 (3.1 ± 0.1 % per day in the main group, 2.9 ± 0.2 % in the control group). The subsequent follow-up showed that the rate of decrease in wound size had increased to 8.2 ± 1.8 % per day on the days 7-14, 5.6 ± 0.9 % on the day 21, with maximal values of 9.66 ± 1.0 % on the days 21-28. Conversely, the control group showed the low rate: 5.8 ± 1.2 % on the days 7-14, 4.1 ± 1.1 % on the days 14-21, 6.3 ± 2.2 % on the days 21-28 (Fig. 3).
Figure 3
Right leg wounds on 14th day after phlebectomy and 3 procedures of ultrasound cavitation
The perifocal edema disappeared faster with use of ultrasonic cavitation in comparison with the common surgical treatment (on the days 1.2 ± 0.2 vs. 2.4 ± 0.5). The advantage of the ultrasonic cavitation technique was noted for all other parameters of the time course of the wound defect. Soft tissue necrosis and fibrin (necrolysis) disappeared earlier (on the days 3.4 ± 0.4 days vs. 5.7 ± 0.8 days in the control group), granulation tissue appeared earlier (on the days 5.6 ± 0.9 in the control group), as well as the events of epithelization (on the days 7.3 ± 1.2 days vs. 11.5 ± 1.3 days in the control group) (Fig. 4).
Figure 4
Comparative results of study of the wound process in the study groups in postsurgical period
The complete healing of the wounds was noted in earlier terms (on the days 26.2 ± 3.4 vs. 32.4 ± 4.1 in the control group) (Fig. 5).
Figure 5
Complete recovery of right leg wounds on 28th day after phlebectomy and 3 procedures of ultrasound cavitation
DISCUSSION
The number of patients with trophic ulcers of the lower extremities has been increasing annually. Such patients often receive recurrent inhospital and outhospital medical care. The variety of techniques and approaches for treatment of trophic ulcers of the lower extremities indicates the absence of the uniform treatment technique, which gives the persistent positive result. Most studies show the efficiency of the staged or combined approach for treatment of trophic ulcers of the lower extremities at the background of chronic venous insufficiency. The first stage is often the same and consists in correction of vertical and horizontal venous refluxes in the system of the great or small saphenous veins. The examples are classic phlebectomy, endovasal laser coagulation, radiofrequency ablation, subfascial dissection of inconsistent perforating veins. The approaches for the second stage are often different, although they are reduced to one action – influence on an ulcerous defect of the lower extremity for its sanitation and faster recovery. Currently, the physical techniques for the wound defect in patients with chronic venous insufficiency have been becoming more important. For example, Popov O.S. [6] et al. stimulated the wound sanitation and formation of granulations by means of preparation of trophic ulcers with use of detergents and through creation of gnotobiote medium in aerotherapeutic sets. S.E. Katorkin et al. [7] used a combination of low-intensive laser irradiance and finely-divided medicinal irrigation of the wound with octenidine dihydrochloride solution in the site of the trophic ulcer. Kokhan R.S. [8] used the vacuum therapy with adequate unload of the injured extremity with use of Medela Basic 30, which sets the level of negative pressure to (-800) mm Hg as the technique of adequate sanitation of the wound defect.
The best short term and long term results of treatment of trophic ulcers with chronic venous insufficiency are achieved with complex treatment with use of various combinations of conservative and surgical techniques. One of the variants of local treatment of venous wounds of the lower extremities is the use of low-frequency ultrasound. The use of ultrasonic cavitation is possible both for primary necrectomy and for scheduled treatment of trophic ulcers with several sessions of ultrasonic impaction. The use of this technique before skin plasty gives the additional decontamination of the wound bed with improvement in subsequent survival of the flap and reduction of time of skin graft retention [9]. The treatment of diabetic trophic ulcers can be performed with ultrasonic cavitation for the first stage of diabetic foot (Wagner’s classification), i.e. in absence of deep lesion of soft tissues [10], which is observed in venous wounds of the lower extremities.
CONCLUSION
The use of several sessions of ultrasonic cavitation of venous trophic ulcers significantly reduces the time of wound clearance and promotes faster recovery by means of efficient suppression of biofilms in the site of the wound defect. The combination of surgical correction of venous refluxes and local ultrasonic influence on the wound improves the outcomes in patients with trophic ulcers of the lower extremities at the background of chronic venous insufficiency.
Information on financing and conflict of interest
The study was conducted without sponsorship. The authors declare the absence of any clear or potential conflicts of interest relating to this article.