THE CHOICE OF A METHOD OF PRIMARY NECRECTOMY IN PATIENTS WITH DIABETIC FOOT

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

 THE CHOICE OF A METHOD OF PRIMARY NECRECTOMY IN PATIENTS WITH DIABETIC FOOT

According to WHO, 5-6 % of the population in the developed countries suffers from diabetes mellitus, with constant increase in the amount of patients that doubles each 10-15 years [1, 2]. Foot trophic ulcer at the background of diabetic foot syndrome is one of the actual problems in surgery for a long time, even at the modern phase of scientific and technical progress, when the main phases of the wound process have been determined and its cellular mechanisms have been studied [3, 4]. Any trophic ulcer is characterized by the chronic course of the wound process. When the period of diabetes mellitus is more than 20 years, the possibility of lesion of the lower extremities is more than 80 %. 40-70 % of all non-traumatic amputations are conducted for patients with diabetes mellitus, and short term postsurgical mortality reaches 20 % and more [5, 6]. A continuous ulcerous defect in absence of appropriate care is a potential cause of abscesses, phlegmon and even fatal complications such as wet gangrene and sepsis [7]. A key phase in treatment of trophic ulcers is surgical preparation and its main component – primary necrectomy. Currently, primary necrectomy is associated with improving results of surgical management of wound and ulcerous defects of the foot in patients with diabetic foot syndrome. It promotes the timely realization of sanitation of a purulent-necrotic focus, removal of wound biofilm and stimulation of granulation tissue formation in ulcer [8]. The conventional knife necrectomy has some limitations relating to possible blood loss that significantly limits its use for patients with burn wounds. It resulted in searching for more spare, but radical techniques [9].
The current possibilities of various types of physical energy added some new techniques of primary necrectomy, which is widely used for treatment of purulent and necrotic lesions of the lower extremities in patients with diabetes mellitus. These techniques include ultrasonic and hydrosurgical dissection [10], but their timing and role for such category of patients have not been determined.

MATERIALS AND METHODS

The efficiency of various techniques of primary necrectomy, clarification of the indications and time of use were estimated in the prospective randomized clinical study of 160 patients with diabetic foot of the stage 1-2 (Wagner M., 1980).  In conditions of the surgery department, Research Institute of Clinical and Experimental Lymphology, the patients were accidentally distributed into 3 groups (the comparison group, the first main group, the second main group).
All included patients signed the informed consent for collecting the research data. The original of the signed consent was retained by the researcher. The duplicate original was given to the patient. The form of the informed consent and the clinical study protocol were confirmed by the local ethical committee and the academic board of Research Institute of Clinical and Experimental Lymphology according to the local regulatory requirements before beginning of the study.
Al study groups received the surgery under local or conduction anesthesia. The anesthetic drug was 0.75 % naropin (5-20 ml).
49 patients of the first group (the comparison group) received knife necrectomy with use of the surgical tools. During knife necrectomy, fibrin deposits and soft tissue necrosis were removed with the standard surgical tools (scissors, a lancet, a small curet).
The patients of the first main group (78 patients) received the ultrasonic necrectomy with Sonoca 300 (Zoring). With use of a special header, the ultrasonic energy was applied for removing necrosis in the wounds (Fig. 1).

Figure 1. Ultrasonic necrectomy with Sonoca 300 (Soring). The wound includes the fibrin deposits and single superficial necrosis of soft tissues

The second group (33 patients) received the necrectomy with use of the hydrosurgical system Versajet I plus (Fig. 2). The thin jet of the saline was used for dissecting soft tissue necrosis and fibrin from the wound surface, with further removing into the suction device. The wounds were irrigated with the antiseptic solutions after surgery. The mean surgery time was 23 ± 5 minutes. After surgery, the wound was dressed with the wound coatings povidone iodine or polypran.

Figure 2. Necrectomy of the foot wound with use of the hydrosurgical system Versajet II plus. The wound has the necrosis of skin and subcutaneous fat tissues

The patients of all groups were similar according to the age, concurrent diseases, severity of diabetes mellitus and diabetic foot syndrome. The disease was characterized as the first stage of diabetic foot syndrome in 70 (43.75 %) patients (Wagner M., 1980). The skin injuries were the superficial defects of the derm, i.e. presence of superficial ulcer. The ulcer bottom was the granulation tissue covered with fibrin deposits. The ulcerous defects were in the region of the first metatarsophalangeal articulation in 10 (14.5 %) patients, in the region of 2nd, 3rd and 4th metatarsophalangeal articulations in 13 (18.5 %) patients, in the region of 5th metatarsophalangeal articulation in 3 (4.2 %) patients, in the calcaneal region in 17 (24.3 %) patients, on the dorsal surface of the foot in 27 (38.5 %) patients. The square of the superficial ulcers was 0.5-4.5 cm2. The superficial ulcerous defects were in the regions with the highest load during walking.
The second stage of diabetic foot syndrome (Wagner M., 1980) with deep lesion of the soft tissues was noted in 90 (56.25 %) patients. At this stage of the disease, the soft tissue defect affected all skin layers and the hypoderm. The square of the ulcerous defect was from 1 to 10.5 cm2.
All patients demonstrated the neuropathic form of diabetic foot syndrome. The presence of the signs of macroangiopathy was a criterion for excluding the patients from the study groups.
The quantitative data was analyzed with the common techniques of the systemic analysis with Excel. The quantitative data is presented as М ± σ (M – mean value, σ – standard deviation). During testing the statistical hypotheses, the critical level of significance was considered as 0.05.

RESULTS

There were not any significant differences in time of edema disappearance in the study groups. On average, the edema disappeared on the day 3 in the comparison group, the first main and the second main groups. In the group of knife necrectomy, the granulation tissue in ulcers appeared on 13th day, in the group of ultrasonic necrectomy – on 9th day, in the group of hydrosurgical necrectomy – on 7th day. The signs of boundary and focal epithelialization appeared on 18th day in the first group, on 13th day in the first main group and on 10th day in the second main group. The ulcers healed completely on 41st day in the comparison group, on 36th day – in the first main group and on 30th day in the second main group.
During the examination of the time of development of the secondary necrosis we used the control points: the days 1-3, 4-6, 7-10 (Fig. 3). Secondary necrosis was identified in the comparison group on the days 1-3 in 18 ± 1.4 %, in the first main group – in 1.2 ± 1.7 %. The necrosis signs were not found in the second main group. On the days 4-6 after primary necrectomy, the secondary necrosis was identified in 26 ± 3.6 % in the comparison group, in 17.5 ± 2.1 % in the first main group, in 16.6 ± 2.4 % in the second main group.

Figure 3. The number of the patients with secondary necrosis after primary necrectomy



Note: 1 – differences are reliable in relation to the comparison group (p < 0.05); 2 – differences are reliable in relation to 1st main group (p < 0.05).

Secondary necrosis was found in 8 ± 0.9 % of the patients in the comparison group, in 7.5 ± 1.1 % in the first main group and in 6.6 ± 0.8 % in the second main group on the days 7-10.
The cytograms of the regenerative type were recorded in 53.76 ± 3.6 % of the cases in the comparison group on the day 21, i.e. the first stage of the wound process shifted to second one after knife necrectomy by the moment of 21st day of the treatment. Such cytograms were noted in 78.3 ± 6.7 % of the clinical cases in the first main group. The cytograms of the regenerative type were noted in 91.3 ± 6.3 % of the cases in the second main group.
The analysis of the time trends of the ulcerous surface showed that the rate of decreasing square of ulcer increased from the group of knife necrectomy to the group of the hydrosurgical system. So, the minimal mean rate of decreasing square of ulcer was recorded in the comparison group (3.57 ± 0.24 % per day). The highest rate of ulcer decreasing was noted in the second group (5.14 ± 0.24 % per day).

DISCUSSION

The aim of treatment of any wounds is correction of skin defects by means of intensifying clarification of a wound in presence of necrotic tissues, arresting the inflammatory process, suppression of pathogenic microflora, replacement of a defect with granulation tissue and epithelialization. Such subsequent and rapid interchange of the phases of the wound process is ideal. However patients with diabetic foot syndrome demonstrate the situation with concurrent metabolic disorders, diabetic angiopathy, and presence in the region of healing. Historically, the solution for the first three tasks is prescription of systemic antibacterial therapy, use of various agents for necrolysis and proteolysis of necrotic tissues, and local administration of antiseptic agents. In a point of fact, acceleration of the wound process in absence of disorders of arterial flow and after their correction consists in reduction of the first phase of the wound process, i.e. wound cleaning. Active surgical management with removal of unviable tissues and the substrate for microflora vegetation, including facultative anaerobic bacteria, is a single alterative at the first glance. But in superficial wound defects, extension of the lesions can cause the chronical course of the wound process because of breakdown of compensatory mechanisms and insufficiency of tissues in the injury region. The conservative techniques for removal of superficial necrotic tissues, biofilms and fibrin deposits, i.e. proteolytic unctures, present not enough radical measures and promote the chronic course. Therefore, the use of the sparing techniques of necrectomy is quite justified. Different types of physical energy are used for this purpose. Some authors fairly note that hydrosurgical dissection and necrectomy for treating extensive wounds can be used as independently as in combination with the conventional techniques of surgical preparation that allow 1.5-fold decrease in the amount of recurrent operations, reducing bacterial contamination of wounds and time of surgery [11]. It is noted that the appropriate use of ultrasonic cavitation and dissection destructs only the tissues with fluid, but perforated vessels from muscles to the skin are reserved [12].
Considering our data, we can conclude the conventional dissection is not justified for diabetic foot of the stage 1 (Wagner) since it increases the extension of injured tissues. From other side, ultrasonic cavitation is less efficient for deep lesions (the stage 2 according to Wagner), and prolongs the surgery time.           

CONCLUSION

The advantage of implementation of the hydrosurgical system is a possibility for regulating the velocity (and energy, as result). It allows using for removal of fibrin deposits and biofilm in superficial lesions, as well as for dissection of rough necrotic tissues in dep lesions.

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