INTRODUCTION
Several techniques have been described to repair
primary cleft palate. Experienced surgeons have
good outcome, still they face complications associated
with cleft palate surgery. To reach the optimum
surgical outcome restoring palatal anatomy
and function, closure in multiple layers to separate
the nasal and oral lining and a tension free closure
is the goal [1].
337
Fistulas are one of the annoying and that may
be common complications following palate repair,
they develop due to wound break down caused by
undesirable wound tension leading to tissue
ischemia, hematoma formation between layers of
repair, infection, trauma to the flap, poor surgical
technique and also due to the severity of the cleft
palate type [2].
Pittsburgh introduced a classification system
which is simple and anatomically based. It includes
seven types “fistula at the uvula or bifid uvula type
I, in soft palate is type II, at the junction of soft
and hard palate is type III, in the hard palate is
type IV, at the incisive foramen is type V, type VI
is lingual-alveolar and type VII are labial-alveolar”
Others described fistulas as intentional (resulting
from unrepaired cleft) or unintentional (due to
wound dehiscence causes) [2].
Fistulas are treated according to functionality
as symptomatic (functional) fistula as the patient
complains of regurgitation of fluid and food, impaired
speech and VPI, or asymptomatic (non
functional) [3].
Apparently it's difficult to repair fistulas due
to scarring and limited mobility of tissues; different
surgical and non surgical techniques were introduced
to manage fistulas. The surgical method
used for fistula repair depends on its site, size,
previous surgical technique used for palate repair,
the amount of scarring and availability of palatal
and surrounding tissues [4].
PRP is used in plastic surgery. Many benefits
were suggested as it promotes wound healing by
regenerating epithelial cells, and increasing angiogenesis.
In addition it's easily prepared, safe for
the patients and being autologous has low rate of
infection [5].
Gonzalez and Jimenez used PRP during closure
of recurrent palatal fistulas as they claimed it
reduced the recurrence rate of fistulas [6], the aim
of this work is to study and evaluate the effect of
PRP during palatal fistula repair and if it is helpful
in decreasing the rate of recurrence of the fistulas.
PATIENTS AND METHODS
20 patients with posterior palatal fistulas were
included in this comparative study; this was done
in the pediatric hospital Cairo University between
September 2016 and September 2017 with followup
by photos after 3 and 6 months postoperative.
All patients were non syndromic cleft palate
patients with posterior palatal fistulas less than 1
cm and their age ranged between 2 to 6 years with
an average of 4 years, with primary palate repair
that was done more than one year.
Detailed history and examination were done to
all patients including evaluation of the velopharyngeal
function using nasopharyngeoscope.
Preoperative laboratory investigations in the
form of:
• Complete blood picture.
• Bleeding profile (PT,PTT and INR).
• Palate swab for culture and sensitivity.
Digital photography (intraoperative, and postoperative
after 3 and 6 months) were taken.
The surgical techniques used for repair of posterior
palatal fistula were either two flap palatoplasty
(9 patients in each group) or Furlow palatoplasty
(one patient in each group).
The patients were divided into two groups,
group A were PRP was injected after the palatal
fistula repair in the edge of the wound between
the nasal and oral layer and group B without PRP
injection with palatal fistula repair.
Operative details:
Patients were operated under general anesthesia
in the supine position with head tilting 20 degrees
for better vision. A systemic antibiotic was given
to the patient. Mouth Gag (Fig. 1) was applied as
the first step at the operating theater after induction
of anesthesia to measure the size of the fistula
using a caliber and pre-operative photos to be
taken.
According to the preoperative plan, if the patient
has VPI, Double opposing Z-plasty (Furlow) procedure
was done. If no VPI, then two flap palato-
338 Vol. 42, No. 2 / PRP Injection Effect on Palatal Fistula Repair
plasty was done. If a concomitant anterior fistula
was present, a buccal mucosal flap or a buccal fat
flap was used to repair the anterior fistula.
Marking (Fig. 2) of the flaps and the site of the
pedicle (the greater palatine artery) was done using
sterile methylene blue before injection of 1/200
000 saline adrenaline and lidocaine.
Under sterile technique 10cc of peripheral
venous blood was aspirated from the patient using
the vacuette blood aspiration kit for the PRP preparation
at this point in a container that has sodium
citrate 3.2%. The sample was immediately centrifuged
using a tabletop centrifuge machine for 10
minutes at a speed of 1000 rpm in the operative
room temperature.
Then the tube is left to suspend for 5 minutes.
Then the upper part of the centrifuged blood is
transferred to another tube, and discarding the red
blood cells. The new tube is then re-inserted in the
centrifuge for 5 minutes at a speed of 2500 rpm.
The blood was separated into three layers based
on density, the bottom layer containing the RBCs,
middle layer containing the PRP consisting of
platelets and WBCs (buffy coat), and the top layer
containing platelet poor plasma (Fig. 3). The pellet
is then aspirated in a syringe with 1cc plasma. The
PRP mixture is left aside till the end of the procedure
to be injected along the edge of the repaired
wound (Fig. 4).
Surgery:
Incisions along the markings were done. Removal
of any fibrous scar tissue from the primary
repair was done. Exploration of the pedicle of the
flaps and identification of the greater palatine
artery was an essential step. Viability of the flaps
was checked according to its color and bleeding
from its edges.
According to the method of repair:
A- In cases of two flap palatoplasty:
Closure was done in an interrupted manner
using absorbable Coated VICRYL sutures 5/0 along
the nasal layer. Lateral relaxing incisions were
done to decrease the tension along the midline
sutures.
B- In cases of Double Opposing Z-plasty (Furlow)
repair:
The oral flap is posteriorly based on the left
side; it is raised with the levator muscle, the right
sided flap above the muscle. The reverse pattern
is planned for the oral side. The nasal flaps are
Egypt, J. Plast. Reconstr. Surg., July 2018 339
transposed and the anterior oral mucosa closed.
The closure was done as well using absorbable
Coated VICRYL sutures. The use of relaxing incisions
was done when necessary.
After closure, the PRP was injected, 5mm away
from the wound edge using a 27G about 0.10ml-
0.15ml was injected at each site between the nasal
and oral layers. Spacing between each injection
site was 1cm.
Applying Soft arm restraints that prevent flexion
at the elbow at the end of the procedure, and it
was kept for two weeks.
All patients were admitted to the in-patient
section for 24 hours for close monitoring and
detecting the early postoperative complications as
hemorrhage & breathing problems.
Patients were given oral antibiotics, pain killers
as paracetamol, oral antifungal and decongestant
nasal drops.
Post-operative feeding instructions as follows:
a- Drinking of clear fluids was encouraged to avoid
oral fungation. The first five days post-operative
only water and clear fluids were allowed.
b- The following five days milk was added to the
previous regimen.
c- And the following five days soft diet was introduced,
by using a syringe. Breast feeding &
bottle feeding were all prohibited for two weeks
after the operation.
Follow-up by photography after the first week
post-operative, and after 3 and 6 months postoperative.
Fig. (1): Applying mouth gag. Fig. (2): Marking.
Fig. (3): After 2nd centrifuge. Fig. (4): PRP prepared for injection
RESULTS
Twenty cases were successfully operated upon
in this study and they were 13 male patients and
7 females, with a fistulas size ranged from 0.6cm
to 1cm, the site of the fistulas according to Pittsburgh
fistula classification system showed that the
patients were of type 3.
Two methods of repair were used, 18 patients
were repaired by two flap palatoplasty technique
and the other two patients were done by Furlow
technique.
They were divided into two groups:
Group A included 10 patients were PRP was
injected with fistula repair, 8 patients continued
their follow-up and two patients had recurrence.
Group B included 10 patients with fistula repair
without PRP injection, 8 patients continued followup
and four patients had recurrence.
340 Vol. 42, No. 2 / PRP Injection Effect on Palatal Fistula Repair
Follow-up photos were taken for both groups:
Intraoperative, 3 and 6 months postoperative.
A total of 16 patients continued their followup
with a recurrence rate of 25% in group A and
50% recurrence rate in group B according to statistical
results and p-value is (0.0508).
Table (1): Count and percentage of recurrence rates of palatal
fistula.
Group
Recurrence:
No:
Count
% Within group
Yes:
Count
% Within group
Total:
Count
% Within group
6
75%
2
25%
8
100%
PRP
4
50%
4
50%
8
100%
Non-PRP
10
62.5%
6
37.5%
16
100%
Total
Fig. (5): Nasal layer closure. Fig. (6): Oral layer closure.
Fig. (7): Closure after Furlow technique. Fig. (8): Injection of PRP after closure.
Egypt, J. Plast. Reconstr. Surg., July 2018 341
Case 1 (study group):
A 5 years old female patient who presented
with an anterior and posterior palatal fistula
(PSFC: Type III). The size of the posterior
fistula was 0.6mm. PRP injection at the end
was done.
Fig. (9): Preoperative showing the fistula. Fig. (10): Intra-operative,2 flap palatoplasty repair.
Fig. (11): 3 months post-operative. Fig. (12): 6 months post operative.
Fig. (13): Preoperative. Fig. (14): Intraoperative using Furlow technique.
Case 2 (study group):
A 3.5 years old male patient presented with
posterior palatal fistula. (PSFC: Type III).
The size of the posterior fistula was 0.6mm.
PRP injection at the end was done.
Fig. (15): One month postoperative. Fig. (16): 6 months postoperative
DISCUSSION
Cleft palate repair is a tough operation due to
a number of factors: Paucity of local tissues, young
age, and the importance of an experienced surgeon.
The most common and challenging complication
following cleft palate repair is palatal fistula, with
a high incidence of fistula after primary palatoplasty
and even higher incidence of re-recurrence after
repair of the palatal fistula. Severity of the fistula
is related to: The type and width of the cleft palate,
the technique used for the primary palatoplasty
repair & the tension over the wound, moreover
persistent postoperative infection leads to oronasal
fistulae [4].
Diah et al., described an algorithm for oronasal
fistulae. After assessment of the patients, they
divided them into two groups: Non-symptomatic
patients and symptomatic patients (with inadequate
velopharyngeal function). Symptomatic patients
were examined using a nasopharyngoscope or a
videofluroscope and performing the fistula occlusion
test. Non-symptomatic patients were treated
conservatively, while symptomatic patients were
treated surgically [7].
Most common complaints of patients with
symptomatic fistulae are leakage of fluids or food,
hypernasality and regurgitation due to both the
fistula and the velopharyngeal insufficiency. Those
kinds of fistulae require surgical management [3].
Different techniques have been used for repair
of different kinds of palatal fistulae such as local
flaps, regional flaps or free tissue transfer. The
choice of which technique to be used depends on
the site and size of the fistula and availability of
local tissues [4].
342 Vol. 42, No. 2 / PRP Injection Effect on Palatal Fistula Repair
The goal of fistula correction is not only closure
of the defect, but also improving the velopharyngeal
function during speech. So, it is recommended to
perform a re-operation using a two flap palatoplasty
or double opposing z-plasty (Furlows technique)
to close the fistula, lengthening the soft palate and
reducing the wound tension [8].
We carried out a comparative study that included
all symptomatic patients with a history of cleft
palate that had been repaired, presented with posterior
palatal fistula for at least one year, who
attended the outpatient clinic during the period
between September 2016 and September 2017.
In this study, the patients were treated according
to the site of the fistula that was mainly at the
junction between the hard and soft palate (Pittsburgh
Fistula Classification, type III), and the size
of the fistula ranged between 2 & 10mm. All of
the cases were managed by using either two flap
palatoplasty technique which is technically easier
and proved to be with low fistula rate postoperative
when compared to other techniques (5.1% for two
flap palatoplasty, 6.6% for Furlow, Wardil-Kilner
12.5%) or Double opposing z-plasty technique
(Furlow) according to the need for correction of
the velopharyngeal dysfunction, as Furlows' technique
is reported to improve the velopharyngeal
competence by lengthening the soft palate by
approaching the soft palate to the posterior pharyngeal
wall [9].
The patients were divided into two groups in
which, group A was operated upon by one of the
previously described techniques (two flap palatoplasty
in 9 cases or double opposing z-plasty in
one case) with the application of platelet-rich
plasma (PRP) injection between the nasal and the
Egypt, J. Plast. Reconstr. Surg., July 2018 343
oral layer. The other group, group B was treated
by using one of the previously described techniques
(two flap palatoplasty in 9 cases or double opposing
z-plasty in one case) without the application of the
platelet-rich plasma (PRP).
Palatal fistula has a high rate of recurrence
following repair. It was reported by Strujak et al.,
that fistula rates range as high as 58% after primary
repair, and up to an average recurrence rate of
nearly 33% after fistula repair [10] we thought of
improving the wound healing process, and having
noted the benefits of PRP offered in other surgical
procedures, we decided to study if its application
with palatal fistula repair could decrease the recurrence
rate.
Clinical application of the PRP in plastic surgery
has been described to have several benefits: It is
easy and rapid to prepare, low relative cost, minimally
invasive, contains abundant amounts of
growth factors that promote regeneration of the
epithelial tissue and improves angiogenesis thus
improves healing of wounds [5], and PRP being
autologous without the addition of any other products
(the technique we use in our study group) so
it is considered a safe method for the patient [11].
In our technique for preparing the PRP, we
selected for the double spin method which activates
the highest therapeutic concentration of the platelets.
First spin is of 1000 rpm for 10 minutes to
ensure that the platelets are suspended in the platelet
rich plasma. In the second hard spin, we concentrated
the platelets at the bottom of the tube into
a pellet that was easily re-suspended, by spinning
at a high speed of 2500 rpm for a short period of
time, for 5 minutes.
Mazzocca et al., compared the double and the
single spin techniques and found that the highest
platelet concentration was achieved using the double-
spin method. The therapeutic concentration of
platelets was not achieved by the single-spin method
[12], the centrifugation force used in the first
spin in our present study was selected according
to that used by Perez et al., who stated a high
platelet recovery using this force [13].
In the present study, we did not activate the
platelets exogenously before its application as this,
according to Scherer et al., [14], would de-granulate
the platelets prematurely with subsequent growth
factors release, which have a very short lifespan.
Also, platelets can be naturally activated by endogenous
collagen as soon as they are injected and so
better results are obtained.
Regarding our statistical results after six months
follow-up of the patients of both groups, by clinical
examination and by post-operative photography,
we found that PRP injection with the repair has
good results in accelerating tissue healing and less
risk of infection. In our study group, the recurrence
rate of the fistula was 25%, while in the control
group the recurrence rate of the fistula was 50%,
which shows an improvement in the recurrence
rate of the palatal fistula, after the surgical repair
with p-value (0.0508).
It was stated by Cohen et al., [15] and Muzaffar
et al., [3] that the rate of fistula occurrence increases
according to the number of previous surgical attempts
to manage the palatal fistulae. In addition,
Gonzalez & Jiménez [6] claimed that they reduced
the recurrence rate of fistula compared to other
studies, by using PRP during the closure of recurrent
cleft palate fistulae.
The results of our study group were satisfactory,
as the rate of recurrence of the palatal fistula was
25% and in comparison, to the control group which
was 50%, and this is due to the beneficial effect
of using the PRP with the fistula repair and it is
proved that its preparation and application is simple
and promotes better healing of scar tissue.
So, we recommend applying PRP during palatal
fistula repair despite of the small sample size in
our study and we recommend increasing the number
of patients in further studies.
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