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<article xmlns:xlink="http://www.w3.org/1999/xlink">
  <front>
    <journal-meta />
    <article-meta>
      <title-group>
        <article-title>Mathematical justification of the wound suturing by wound contractors of new generation</article-title>
      </title-group>
      <contrib-group>
        <aff id="aff0">
          <label>0</label>
          <institution>ANO "Research Center for Physical and Technical Informatics"</institution>
          ,
          <addr-line>Nizhny Novgorod</addr-line>
          ,
          <country country="RU">Russia</country>
        </aff>
        <aff id="aff1">
          <label>1</label>
          <institution>GKB No.</institution>
          <addr-line>35, Nizhny Novgorod</addr-line>
          ,
          <country country="RU">Russia</country>
        </aff>
        <aff id="aff2">
          <label>2</label>
          <institution>Nizhny Novgorod State University of Architecture and Civil Engineering</institution>
          ,
          <addr-line>Nizhny Novgorod</addr-line>
          ,
          <country country="RU">Russia</country>
        </aff>
        <aff id="aff3">
          <label>3</label>
          <institution>S.G. Izmaylov</institution>
        </aff>
      </contrib-group>
      <abstract>
        <p>Frequent cases of man-made disasters, terrorist attacks and military conflicts lead to an increase in the number of victims. Significant soft tissue defects are known to result from gunshot wounds. So, as a result of mine-blasting injuries, defects in the skin and underlying tissues more than 10 cm in diameter are formed in 71.1% of cases. The prerequisite for the uncomplicated course of the wound process is to achieve an adequate comparison of the edges of the wound without excessive tension. To close such extensive wounds, various technical means are used: sutures on pads, various types of dermatotension. We have developed various models of wound contractors (RC) for treatment of wounds. With the help of the RC, a complete reposition and good adaptation of the edges of the wound is created. The wound closure method using these RC almost completely eliminates tissue cutting and limits the sawing effect to a minimum. This is explained by the effects of elastic forces reducing to zero when matching soft tissues and suturing. The use of hardware methods for suturing wounds requires the development of mathematical models of various types of wounds and surgical sutures. These models should provide a simulation of living tissues of the wound edges behavior to achieve the best results in the treatment of wounds by RC advanced technologies. The purpose of this study is to mathematically justify RC with the parallel holding of spokes. Another purpose is to develop a mathematical model of the wounds suturing by hardware technology.</p>
      </abstract>
    </article-meta>
  </front>
  <body>
    <sec id="sec-1">
      <title>1. Introduction</title>
      <p>
        The mathematical justification of the spoke
adaptationrepositional contractors (SPARC) and methods for
suturing wounds was carried out by standard formulas and
methods adopted in mechanics [
        <xref ref-type="bibr" rid="ref1 ref2 ref3">1-3</xref>
        ]. Mathematical
calculation and formulas derivation were consulted by the
assistant professor of the Department of Theoretical
Mechanics of Kazan State University Tazyukova F.Kh.
      </p>
      <p>The wound mathematical model was developed together
with Professor E.V. Popov and Professor S.I. Rotkov.</p>
      <p>The experimental part of the work was performed on
18 outbred dogs, weighing 14.5 ± 0.7 kg, which were
divided into two groups: experimental (hardware method
of suturing) and control (traditional method of suturing).</p>
      <p>An extensive granulating wound was modeled according
to the method of V.I. Struchkov (1975) in our
modification.</p>
      <p>In order to reduce the morbidity of stitched tissues, we
used a spoke (Sp) adaptation-reposition apparatus (ARA)
(SPARC-III) that we developed to bring the edges of the
granulating wound closer in the animals of the main group.</p>
      <p>This device for converging the wound edges is protected
by Patent for invention No. 2214797, filed January 8, 2002
and published on October 27, 2003 in Bulletin No. 30 S.</p>
      <p>G. Izmaylov, V. V. Beschastnov, A. A. Bodrov, M. N.</p>
      <p>Kiselev, M.N. Kudykin. (A positive FIPS decision on the
grant of a patent of the Russian Federation dated 01/18/02.</p>
      <p>On the application for invention No. 2002100973). The
device contains two branches (Fig. 1), a rack-and-pinion
drive and spokes, characterized in that the spokes are made
in the form of curved surgical spokes, comprising 1/2 - 5/8
of the diameter of the circle and installed with the
possibility of fixation by presoft tissueated branches made
of two corrugated plates on internal surfaces. In this case,
one of the plates is removable, and in the end part of the
other, a turnkey 3- or 4-sided groove is made for
alternately turning the branch in the cylindrical sockets of
the rack-and-pinion drive, which is equipped with screw
clamps for turning the branches, which can be fixed by
rails to each other.</p>
      <p>Fig. 1. General view of SPARC -III for rapprochement of the edges of a granulating wound in a prefabricated form with removable
branches and spokes made in the form of curved surgical needles</p>
      <p>The ARA was removed after suturing in the 1st series
of the experimental group of animals, and in the 2nd series,
it remained on the wound for up to 3 days. In this case, the
rack-and-pinion drive was removed. Capron No. 4 was
used in control group, and sterilized and factory-packed
suture material in experimental group No. 2.</p>
      <p>Microbiological studies were carried out on the basis
of
the
its entire length were carried out by the dynamometric
method (Ramazanov R.M., 1983; Izmailov S.G., 1994).</p>
      <p>The thickness of the tissues in the area of the wound
sutured edges was measured with a caliper.</p>
      <p>To assess the state of the microvascular bed around the
wound
during tissue tension, a study</p>
      <p>of the skin
temperature was carried out in dynamics (Struchkov V.I.,
1975). The skin temperature was measured with a TEN-5
electronic thermometer, manufactured in 2001 (Moscow),
intended for use in medicine and veterinary with 0.1°C
resolution.
08.22.77.</p>
      <p>All animal operations were carried out in compliance
with the order of the USSR Ministry of Health No. 755 of
2.</p>
    </sec>
    <sec id="sec-2">
      <title>Results and discussion</title>
      <p>The entire devices is subdivided according to the
bringing together
mechanism
working
part into the
following main subgroups: 1 - spoke, 2 - lamellar, 3
filament, 4 - spoke and 5 - rod.</p>
      <p>Depending on the wound location and shape, the RС
are divided into: general (for all wounds) and special (for
operations on the limbs, etc.). By appointment, the RС are
divided into the following types: fixation (for gripping and
holding tissues); hemostatic (for temporary, preventive or
final
stop
of
bleeding);
immobilization;
for
the
implementation of programmed rehabilitation of the
pathological hotbed.</p>
      <p>The most universal devices are SPARC with parallel
holding of spokes relative to the axis of the wound. The
goal of the work is to substantiate the use of curved
knitting spokes in parallel by the methods of mathematical
modeling. The feasibility of using bent knitting spokes is
justified by the following circumstances.</p>
      <p>We assume that the place of entry A (A0) and the place
of exit B (B0) of these spokes coincide. Denote by l the
length of the straight spoke in the soft tissue, l0 the length
of the curved spoke in the soft tissue (l0 &gt; l) (Fig. 2).
we obtain the following inequality
 0 =  ∙  ,  = 2
∝
=

∝
∝
2</p>
      <p>Let us plot the relationship between the pressure ratio
of the curved spoke and the straight spoke as a function of
the central angle α of the curved spoke (Fig. 3).
(5)
points of the spokes; F [H] - the total force acting from the
side of the device on the tissue.</p>
      <p>Let us evaluate the spokes pressure q [H / m] to the
tissue. We will consider two factors. First, an increase in
the number of N pairs of spokes. Assuming that the length
of the spoke in different pairs varies slightly, we can
assume that the force P acting on one spoke is
approximately equal to P = F / N.</p>
      <p>An increase the number N of pairs of spokes decreases
their pressure q on the tissue (q = P / l). For uniform
pressure on the fabric, it is necessary to arrange the spokes
at different depths and distances. It is necessary that the
distance between the spokes is greater than their diameter
d [m], since they do not affect on the tissue at the distance
greater than d.</p>
      <p>Second, deformation of the skin tissue and adjacent
soft tissues at the points of entry / exit of the spoke occurs.</p>
      <p>In places of entry / exit to the spoke, skin and adjacent
soft tissues, P / 2 forces act (Fig. 5).</p>
      <p>Therefore, in the places of entry / exit of the spokes soft
tissue is crushed. The creasing of the fabric will occur due
to the tangential forces τ, which are determined by the
following expression
(6)
 =</p>
      <p>2
2
.</p>
      <p>It follows from (6) that an increase in the number of
spokes reduces the trauma of the skin at the points of entry
and exit of the spokes.</p>
      <p>Thus, the implementation of spokes in the form of
curved surgical spokes in the form of 1/2 - 5/8 of the
diameter of the circle provides a deep and wide capture of
tissues of the edges of the wound in a limited area. This
reduces the morbidity of the wound edges and improve the
adaptation of wound surfaces with deep soft tissue defects
healing by secondary intention. Fixing SPARC-III to the
skin with spokes in the form of surgical needles in 5/8 of
the circle diameter allows the device to be used to reduce
the edges of small wounds when the use of more bulky
spoke devices is traumatic. An increase in the number of
curved spokes, parallel to the branches and with the
possibility of moving in horizontal and vertical directions,
allows tissue traction at different levels determined by the
depth of the spokes simultaneously or alternately turning
on or off a pair of spokes, reduces tissue trauma to all
layers of the wound edge.</p>
      <p>The data obtained in an animal experiment confirmed
mathematical calculations. Thus, the experimental studies
showed that the closure of the granulating wound in the
experiment (using hardware) occurred in more favorable
conditions
with
the
possibility
of
using
precision
technology and thin suture threads (Capron No. 2, thread
diameter 0.25 mm). In the control group of animals joining
the wound edges was possible only when using Nylon
thread</p>
      <sec id="sec-2-1">
        <title>No. 4 (thread diameter 0.45</title>
        <p>mm).</p>
        <p>With this
diameter, the suture material retained its initial strength,
and during visual inspection there were no signs of
excessive threading of the tissue with the thread at the time
of wound closure. The breaking load of the used suture
material with a diameter of 0.25 mm and 0.45 mm was on
average (M ± m) 9.9 ± 1.2 N and 33.4 ± 2.3 N, respectively
(p &lt;0.05). The use of RC completely excluded the
“sawing” action of the thread observed with the traditional
method of suturing. The experiments showed (table 1) that
when using the RC, a stress distribution in the weld area
that is safe in terms of healing is achieved.</p>
        <p>According to electro thermometry, the average skin
temperature of healthy tissues in the wound area in the
control group was (M ± m) 29.7 ± 0.3 ° C, and in the main
group 29.8 ± 0.2 ° C (p&gt; 0.05 ) In the stage of purulent
inflammation, the temperature of the perivular zone in the
area of the purulent wound decreased (p &lt;0.05) to 26.2 ±
0.2 ° C and 26.1 ± 0.1 ° C, respectively, and in the
regeneration phase before suturing it reached the initial
values (29.7±0.4 and</p>
        <p>29.4±0.3, respectively). In the
control group, when wounds were sutured in the traditional
way, when the sutures were tightened and the edges of the
wound were tensioned, the skin temperature in the area of
the suture line decreased by an average of 1.8 ± 0.4 ° C (p
&lt;0.05), and in the experimental group compared to the
initial ones figures on average 0.6 ± 0.1 ° C (p &lt;0.05). The
differences between the gradients of temperature reduction
in the control and experiment are statistically significant
(p &lt;0.05).</p>
        <p>It was found that when suture material was passed
through the tissue of a granulating wound, in 100% of
cases of both experimental and control groups of animals,
suture
material
was
contaminated.</p>
        <p>Most
often,
S.epidermidis was found in the studied material in a
monoculture or in
associations
with</p>
        <p>S.aureus
and
E.faecium, and the average microbial number averaged in
the experimental group (3.4 ± 0.8) · 101 CFU / cm suture
and ( 3.3 ± 0.8) 101 CFU / cm - in the control. Three days
after suturing, the number of microorganisms on the suture
in the experiment did not significantly increase from the
statistic and averaged (4.1 ± 0.7) 101 CFU / cm. At the
same time, in the animals of the control group there was a
significant increase in the number of microorganisms to
(3.5 ± 0.6) 105 CFU / cm. Moreover, an increase in
bacterial
contamination
of
suture
material
was
accompanied by an increase in the frequency of detection
of pathogen associations on suture material in this group
of animals. The studied state of the wound edges tissue in
the subsequent healing
periods showed that
wound
complications occurred more often in the control group
than in the experimental group. So, on the 3rd day after
suturing in 4 of 6 animals of the control group,
purulentinflammatory complications (infiltrates, suppuration of the
wound, teething) from the side of the
wound
were
clinically observed. All animals in the control group
revealed partial eruption of sutures. In 2 series of the
experimental group, only in 1 case out of 12 there was
suppuration of the postoperative wound in a limited area,
requiring removal of 1 suture (rTMP &lt;0.05). In the
remaining 11 observations, wound healing was of the type
of primary tension.</p>
        <p>The wound tensiometry showed that at the 3rd day
after suturing the experimental group the average rupture
of the scar was (M ± m) 21.7 ± 0.6 kPa in 1 series and 22.6
± 0.5 kPa in 2- th and was respectively 1.6 and 1.7 times
higher (p &lt;0.05) than in the control group (13.6 ± 1.0 kPa).
The differences between the first and second series in the
experimental group are statistically insignificant (p&gt; 0.05).</p>
        <p>The histology confirmed the results obtained by
tensiometry at the microscopic level. Zones of primary
alteration were found in the entire control group of animals
immediately after suturing of the granulating wound in a
cross section of the suture area, the tissue was teething
while reducing the wound edges and tightening the knot.
With a hardware method for wound suturing, the alteration
zone was limited only by the diameter of the thread
without additional eruption of tissue. Compared with the
control group of animals, large hotbeds of necrotic
changes were not detected. At the same time, the structure
of surrounding tissues was preserved.</p>
        <p>Three days after suturing by the traditional suturing
method vertical and horizontal sections around the suture
threads showed signs of massive tissue destruction in the
form
of large necrosis fields saturated
with purulent
exudate. In this case, not only tissues bordering the
channel of the thread were exposed to necrosis, but also
distant areas located on the line of tension of the thread.
The cause of these necrosis could be both the mechanical
effect of the thread on the surrounding tissue during
contraction of the wound edges (direct necrosis), and
vascular disorders in distant areas in the form of sweets,
blood
clots
(indirect
vascular
necrosis).</p>
        <p>The
intracanalicular pathway of infection spread is obvious,
since leukocytes were found not only at the edges of the
thread channel, but also in the channel itself, as well as
between the elements of the thread.</p>
      </sec>
      <sec id="sec-2-2">
        <title>In the granulating</title>
        <p>wound, which was sutured by
hardware, the cellular infiltration of stitched tissues was
significantly less compared to the control, which indicated
a weak severity of the inflammatory reaction.</p>
        <p>Thus, the
conducted
experimental
studies</p>
        <p>have
established that the convergence of the rigid edges of the
granulating wound using the suture in the traditional way
under the conditions of tensile forces, the tightening of the
sutures leads to the formation of primary hotbed of
necrosis in the
sutures
and
edges of the</p>
        <p>wound,
intraoperative eruption of the suture, hemorrhages and
reduced vascularization of stitched tissues. This is the
reason for the decrease in local resistance of tissues to
infection, their
regenerative
ability,
which</p>
        <p>creates
unfavorable conditions for the course of the wound
process and thereby significantly increases the risk of
purulent-inflammatory
wound</p>
        <p>complications even in
conditions of low microbial contamination of the wound
surface, when the number of microbial bodies does not
exceed the critical level 105 CFU.</p>
        <p>In contrast to the traditional suturing method the
closure of the granulating wound using the RС is carried
out without suture thread. The latter is used only to keep
the edges of the wound defect at a reduced state. This
achieves anatomically accurate reconstruction of tissues in
the wound area, minimal damaging effect on stitched
tissues, complete elimination of the “sawing” effect of the
thread and its eruption at the moment of matching the
wound edges. In addition, optimal conditions are provided
for adequate blood supply in the area of a wound defect.</p>
        <p>This increases the resistance of local tissues to infection
and reduces the risk of wound suppurative inflammatory
complications.</p>
        <p>When modeling the process of suturing a wound, an
important step is the selection of a soft tissue model. Some
existing
models created for different purposes</p>
        <p>
          were
analyzed: finite element model [
          <xref ref-type="bibr" rid="ref1">1</xref>
          ], various point models
[
          <xref ref-type="bibr" rid="ref4 ref5 ref6">4-6</xref>
          ]. In [
          <xref ref-type="bibr" rid="ref7">7</xref>
          ], the advantages and disadvantages of these
representations of soft tissue for modeling were described.
        </p>
        <p>
          Based on the analysis of numerous studies in various
industries, the authors of [
          <xref ref-type="bibr" rid="ref2 ref8">2, 8</xref>
          ] propose a generalized
formulation of the Stretched Grid Method (SGM), which
is a kind of grid
        </p>
        <p>methods that allows very efficient
modeling of the behavior of equilibrium continuum by
representing it as an energy-equivalent grid structure. The
generalized formulation assumes the presence of external
influences on the system in the form of superimposed
elastic nodal bonds and nodal pseudo-loads, which allows
us to simulate external constrains and continuum loads,
namely</p>
        <p>Π = ∑
 =1     2 + ∑3=1(∑ =1   (Δ  )2 − ∑ =1</p>
        <p>Δ  ), (7)
where n is the total number of mesh segments, m is the
total number of mesh nodes, Rj is the length of segment
number j, D is the stiffness of the segments (assumed to be
the same for all), ΔXik is the increment of the coordinate of
the kth node along the i axis, Cik is stiffness of the elastic
bond in the node number k along the i-axis, Pik - external
load in the node number k along the i-axis.</p>
        <p>
          It is assumed that soft tissue is a continuum modeled
by an equivalent grid structure, which is a set of point
masses connected by springs. In [
          <xref ref-type="bibr" rid="ref4 ref5 ref6">4-6</xref>
          ], the following law
of motion was obtained for node number i of the
nodalspring model

  2 2 = −

   + ∑ ∈ ( )   ,
0
  , −    
   
    ,
        </p>
        <p>(8)
where μ is the mass of the point, γ is the damping
coefficient, Ki,j is the stiffness coefficient of the spring
connecting the i and j points, N (i) is the set of points
connected to this, l0i,j is the distance between the i and j
points in an unstressed state.</p>
        <p>Minimization
of functional (7)</p>
        <p>with respect to
unknown nodal changes in the coordinates of the points
allows obtaining a relationship that differs from equation
(8) only in the inertial term on the left equation side and
the first term on the right, which reflects the damping
properties of the tissue model. Thus, SGM allows the
formation of a nodel-spring</p>
        <p>model that is in good
agreement with those developed earlier. The advantage of
SGM is in solving the problem in a quasi-static setting,
which greatly simplifies the solution of the problem. This
formulation can be used in both static and dynamic
settings. Minor modifications of relation (7), related to the
inertial and damping components allows obtaining the
corresponding equations of motion of an elastic grid with
point masses, which can be solved using step-by-step
algorithms. Modeling of cuts and seams is done by
removing or creating bonds between the corresponding</p>
        <p>When using a grid structure with point masses for
modeling soft tissue the following problems need to be
point masses.
solved</p>
        <p>The bonds topology. The number and arrangement of
bonds between the masses greatly affects the behavior
of the entire system. If the number of bonds is
insufficient or there are too many of them, the model
will not reflect the actual behavior of the soft tissues.</p>
        <p>Because of these they are usually limited to a regular
lattice structure.
2. Physic-mechanical properties of grid segments. The
problem lies in determining the bond properties
between the masses for the correct modeling of soft
tissues.</p>
        <p>The model for studying the process of suturing a
wound using RC is a regular 3D grid with point masses in
nodes, which represents soft tissues of various properties.</p>
        <p>Bonds between nodes between nodes have only
tensilecompression rigidity and act as springs. Three main
aspects can be distinguished that affect the consistency of
the real tissue model
1. Nodes of regular grid. Different masses of nodes
model different layers of tissue that have different
density.</p>
        <p>2. The grid topology. The hexagonal regular grid
structure is not enough. Therefore, additional diagonal
bonds were added (see Fig. 6).
3. Grid bond properties. Different elastic parameters for
bonds between point masses can be applied to
simulate different layers of different tissue elasticity.</p>
        <p>
          In [
          <xref ref-type="bibr" rid="ref1">1</xref>
          ] data of the tissue elasticity obtained by
vibroelastometry. These data were used to set the
quantitative characteristics of model grid correctly.
        </p>
        <p>To simulate the process of wound suturing it is
necessary to simulate an incision of the desired size and
shape. In our grid tissue model this can be done by
eliminating the bonds between the corresponding nodal
masses. The cut is formed automatically due to the tension
in the tissue itself.</p>
        <p>The approach of the wound edges by RC is
schematically shown in Fig. 7. and consists of the
following steps:
1. The intrusion of special curved spokes into the tissue.
2. Straightening spokes.
3. Converging of the edges of the wound with the help</p>
        <p>of branches on the spokes.</p>
        <p>Fig. 7. Converging the wound edges by RC</p>
        <p>In order to simulate the converging of the wound edges The knowledge obtained on the basis of this
the corresponding nodes in the regular grid are declared to mathematical model of wound closure by various RC
belong to spokes or branches. In this case, all connections options allows optimizing the constructive part of devices
with these nodes are saved. Next, you need to set the for their more effective practical application.
trajectory and speed of these nodes. Thus, the deformation An analysis of patient’s treatment with granulating
of tissues during the straightening of spokes can be wounds showed that the use of RС with perpendicular
determined by comparing the geometry of the undeformed holding of spokes and needles can lead to cosmetic defects
and deformed grid, taking into account the physical and due to the frequency of purulent-inflammatory
mechanical properties of the grid segments. complications with overall good and satisfactory healing.
This was confirmed by our research in the mathematical
modeling of the process of suturing soft tissue wounds.</p>
        <p>Significantly fewer complications were observed when
using the RC with parallel edges of the wound using
curved knitting needles (22.6% and 11.8%, respectively).</p>
        <p>Purulent-inflammatory complications developed in 17.1%
with hardware and in 59% of cases with the traditional
method of suturing (p &lt;0.05).</p>
        <p>The hardware application to the treatment of
abdominal hernias reduced the number of postoperative
wound complications from 29.1 to 10.3% (p &lt;0.001), the
number of complications from the bronchopulmonary and
cardiovascular systems from 11.4 to 4% (p &lt;0.005), the
number of relapses from 15.8 to 1.9% (p &lt;0.001), which
can primarily be explained by a decrease in the trauma of
stitched tissues and the reliability of closing a wound
defect.</p>
      </sec>
    </sec>
    <sec id="sec-3">
      <title>3. Conclusion</title>
      <p>The wound edges convergence is a preparatory
operation for suturing. However, in such a formulation it
is already possible to give not only a qualitative, but also
a quantitative assessment of the clinical efficacy of
different RC constructs. To do this, it is necessary to
develop an algorithm for assessing the damage that tissue
receives when various wound devices are applied to it.</p>
      <p>The next step in modeling should be the wound
suturing in the state after applying the RC. The developed
mathematical model can be used for subsequent
optimization of wound suturing technology in a clinical
setting.</p>
      <p>The developed mathematical model is applicable for
studying the process of suturing a wound using RC from
beginning to end.</p>
    </sec>
    <sec id="sec-4">
      <title>Acknowledgment</title>
      <p>The work was performed according to the RFBR grant
No. 19-07-01024.</p>
    </sec>
  </body>
  <back>
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