Keywords
middle ear effusion - nasal surgery - acoustic impedance tests - auditory tube - splints
Introduction
Septoplasty is one of the surgeries most frequently performed for the treatment of
nasal obstruction in otorhinolaryngology clinics. Following surgery, temporary eustachian
tube (ET) dysfunction is a common problem due to nasal packing, and it is believed
to be caused by the absence of nasal airflow and inflammatory mediator release.[1]
[2] This problem is more common when using packs that completely block the nasal passage.
Studies[3] have shown that commonly used silicone nasal septal splints with integral airways
cause lower levels of nasal obstruction and negative pressure in the middle ear because
they enable nasal airflow through an integral airway and provide septal support.
Bioabsorbable packs, which are frequently used after nasal surgery nowadays, are thought
to be more comfortable than removable packings. One of the absorbable packs is PosiSep
X (Hemostasis, LLC, St. Paul, MN, United States) which is chitosan-based and non-synthetic.
It is a biologically inert and self-dissolved material that enhances wound healing
and minimizes bleeding.[4] Recently, it began to be used after endoscopic sinus surgery and septoplasty in
our clinic. Although it is used frequently, up to date, there is no study in the literature
on its effect on middle ear ventilation and pressure following nasal surgery. Therefore,
we aimed to compare the effects of PosiSep X and silicone nasal septal splints with
integral airway on the ventilation and pressure of the middle ear after septoplasty
in patients with normal otoscopic examination.
Methods
The present study was conducted after the approval of the institutional Ethics Committee
(approval date: July 5th, 2021; no.: 115). Signed informed consent was obtained from
all participants. Patients who underwent septoplasty for nasal septal deviation with
otoscopically-normal tympanic membranes and bilateral, normal type-A preoperative
tympanograms were included. Patients aged under 18 years and those who had turbinate
or paranasal sinus pathologies and allergic rhinitis were excluded. Following surgery,
the patients were randomized into two groups, one comprised of patients who were submitted
to the application of silicone nasal septal splint with integral airway (Unosplint,
Genco Tibbi Cihazlar San. Tic. Ltd., Konak, İzmir, Turkey) (group S) the other group
comprised of patients who were submitted to the application of hemostat dressing/intranasal
splint (PosiSep X, Hemostasis, LLC) (group P) for the nasal packing. The Unosplint
was completely removed on the second postoperative day, as we have been doing for
a long time in our clinic, while, for PosiSep X, only the portions around the nasal
nares were aspirated for cleaning, without removing the entire pack. The middle ear
pressure (MEP) of the included patients was measured pre- and postoperatively through
tympanometry. Alterations in MEP were also measured pre- and postoperatively through
tympanometry using an impedance audiometer (AZ-26, Interacoustics A/S, Middelfart,
Denmark). Tympanometry was repeated 24 hours after surgery, just before the removal
of the nasal packs on the second day, and, finally, on the seventh postoperative day.
The results for each ear were analyzed separately. The tympanograms were classified
as originally described by Jerger.[5]
Statistical analyses were performed using the IBM SPSS Statistics for Windows (IBM
Corp., Armonk, NY, United States) software, version 22.0. The Chi-squared (χ2) test was used to compare the categorical variables. The MEP level variables were
not normally distributed according to the Kolmogorov–Smirnov normality test. Therefore,
nonparametric tests were used to compare the MEP values. The Mann-Whitney U test for
two independent samples was used to compare the continuous variables regarding groups
P and S. The Friedman test and the Wilcoxon signed-rank test with a Bonferroni correction
were used to compare the tympanometric pressure preoperatively and on the first, second,
and seventh postoperative days pressures. Repeated measures two-way analysis of variance
(ANOVA) was used to compare the alterations in pressure between the two groups. The
continuous variables were expressed as median and interquartile range (IQR) values.
Values of p value < 0.05 were considered statistically significant.
Results
The present study included 60 (28 male and 32 female) patients, with 30 participants
in each group. There were no statistically significant differences between the two
groups in terms of age and gender ([Table 1]).
Table 1
Demographic analysis of the study sample
|
|
PosiSep X group
|
Silicone nasal septal splint group
|
p-value
|
|
Mean age in years
|
|
31.53 ± 10.29
|
32.66 ± 8.90
|
0.33
|
|
Gender: n (%)
|
Female;
male
|
15 (50)
15 (50)
|
13 (43.3)
17 (56.7)
|
0.605
|
|
Tobacco use: n (%)
|
Negative;
positive
|
25 (83.4)
5 (16.7)
|
21 (70)
9 (30)
|
0.222
|
The tympanometric pressures decreased in all patients in both groups, but more so
in group S in the first 24 hours following surgery. After 24 hours, the MEP started
to increase in both groups, and it almost reached the preoperative values by the 48th
hour in group P. These pressure differences between the 2 groups in the first 48 hours
following surgery were statistically significant. In both groups, the MEP returned
to the preoperative values by the seventh postoperative day, except for one patient
in group S.
All MEP values ≤ -100 daPa (by definition, classified as type-C tympanograms) were
considered pathological. Pathological decreases in the MEP of at least one ear were
observed in 5 patients in group P and in 2 patients in group S 48 hours after surgery,
but this difference was not statistically significant ([Figs. 1]
[2]; [Table 2]).
Table 2
Tympanometric pressures measured preoperatively and on the first, second, and seventh
postoperative days
|
Tympanometric pressure
|
PosiSep X group
|
Silicone nasal septal splint group
|
p-valuea
|
|
Right ear
|
Preoperative;
postoperative: first day;
second day;
seventh day;
p-value;b
p-value;c
|
-28.0 [13];
-40.0 [37];
-28.0 [30];
-24.0 [13];
0.017;
< 0.001
|
-22.0 [16];
-62.0 [113];
-52.5 [64];
-21.0 [16];
< 0.001
|
0.103;
0.021;
0.001;
0.466
|
|
Left ear
|
Preoperative;
postoperative: first day;
second day;
seventh day;
p-value;b
p-value;c
|
-24.0 [20];
-36.0 [32];
-32.0 [28];
-26.0 [21];
0.001;
0.014
|
-22.0 [19];
-56.5 [93];
-45.0 [58];
-22.0 [19];
< 0.001
|
0.529;
0.006;
0.219;
0.468
|
Notes:
aResults of the comparison between the two groups. bResults of the comparison of the pressures measured preoperatively and on the first,
second, and seventh postoperative days. cResults of the comparison between the two groups regarding alterations in pressure.
Fig. 1 |Graph showing the changes in middle ear pressure in the right ears of groups P (patients
with PosiSep X [Hemostasis, LLC]) and S (patients with silicone nasal septal splints).
Fig. 2 Graph showing the changes in middle ear pressure in the left ears of groups P and
S.
In group P, 48 hours postoperatively, 2 patients presented bilateral type-C tympanograms,
and 3, unilateral type-C tympanograms, but type-B tympanograms were not observed in
any of the patients. In group S, 1 patient presented a unilateral type-C tympanogram,
and another patient, a bilateral type-C tympanogram 48 hours following surgery. Likewise,
no type-B tympanograms were observed in any of the patients in group S.
Tympanometry performed 5 days after the removal of the nasal packs revealed normal
type-A tympanograms for all ears in group S. Although 29 patients returned to normal
type-A tympanograms in group P, 1 patient still presented a type-C tympanogram in
both ears. No patient in either group presented a type-B tympanogram during the study
period. Furthermore, no otoscopic or tympanometric evidence of middle ear effusion
was observed in any patient in either group, including those with type-C tympanograms
([Table 3]).
Table 3
Tympanogram types of the two groups measured on the first, second, and seventh days
postoperatively
|
PosiSep X group (n)
|
Silicone nasal septal splint group (n)
|
|
|
Tympanogram type
|
A
|
B
|
C
|
A
|
B
|
C
|
p-value*
|
|
Right ear
|
First postoperative fday
|
24
|
0
|
6
|
27
|
0
|
3
|
0.278
|
|
Second postoperative day
|
25
|
0
|
5
|
28
|
0
|
2
|
0.228
|
|
Seventh postoperative day
|
29
|
0
|
1
|
30
|
0
|
0
|
0.313
|
|
Left ear
|
First postoperative day
|
24
|
0
|
6
|
26
|
0
|
4
|
0.488
|
|
Second postoperative day
|
28
|
0
|
2
|
29
|
0
|
1
|
0.554
|
|
Seventh postoperative day
|
29
|
0
|
1
|
30
|
0
|
0
|
0.313
|
Note: *Pearson's Chi-squared test.
Discussion
The ET is a functional passage between the middle ear and the nasopharynx that provides
ventilation to the middle ear. It is frequently involved in pathological processes
affecting the nasal, paranasal and nasopharyngeal cavities.[6] Salvinelli et al.[7] reported that chronic nasal obstruction is a frequent cause of ET dysfunction which
can lead to middle ear hypoventilation. The inflammatory reaction and edema in the
nasopharyngeal mucosa due to surgical trauma and packing is believed to cause ET dysfunction.
Nasal packs are used to prevent bleeding and support the septal mucoperichondrial
flap to minimize the risk of septal hematoma and synechiae following nasal surgery
and epistaxis. Several packing materials, including vaseline gauze, Merocel (Medtronic
plc, Minneapolis, MN, United States), and septal splints, have been used following
septoplasty, as they all present their own advantages. It is expected that the insertion
and removal of the nasal packing does not cause pain. Furthermore, it should be easily
removable and cause less nasal fullness.
Negative MEP measured by tympanometry is a sign of ET dysfunction, a complication
caused by nasal packings after septoplasty that is usually reversible. However, it
causes patient discomfort and dissatisfaction following surgery. In a study using
bilateral anterior nasal gauze packs following septoplasty, Thompson and Crowther[8] found 46% of patients with a negative MEP, lower than -50 dPa. Moreover, Mc Curdy[1] reported a negative pressure ≤ -100 daPa in 25% of 99 ears 3 days after applying
bilateral anterior nasal packing.[1] In the current study, a type-C tympanogram was obtained in at least 1 ear in 5 patients
in group P and in 2 patients in group S 48 hours after septoplasty.
Merocel and silicone splint have recently become the preferred material among packing
alternatives following septoplasty. Since it enables nasal breathing through an integral
airway, the silicone nasal septal splint with integral airway is believed to cause
lower levels of negative pressure in the middle ear and increase patient comfort postoperatively.
Several studies[3]
[9]
[9]
[10] comparing Merocel and silicone splints after septoplasty have shown that silicone
splints with integral airway cause lower levels of ET dysfunction and aural fullness
than Merocel postoperatively.
Due to patients' stress and fear of packing removal, bioabsorbable materials that
do not require removal have been recently used as packings after nasal surgery. Furthermore,
absorbable packs are more comfortable than removable packs.[11] Among them, the preferred packs are Nasopore (Stryker Corporation, Kalamazoo, MI,
United States), a synthetic polyurethane pack, and PosiSep X, a chitosan-based non-synthetic
nasal pack. Both are self-dissolved and biologically inert materials. They also enhance
wound healing and minimize bleeding. Previous studies[11]
[12] have shown that absorbable packs, which reduce pain and discomfort during packing
and removal following nasal surgery, are efficient and safe. Khafagy and Maarouf[13] compared the clinical outcomes of the use of Nasopore and PosiSep X after functional
endoscopic sinus surgery. They reported that both packs are efficient and safe regarding
mucosal healing and bleeding control. PosiSep X showed a higher advantage in the first
two weeks regarding the amount of the retained material crusting as well as bleeding
in their study.[13]
Although there are studies on the effectiveness of absorbable packs after nasal surgery,
there is no study in the literature on their effects on ET function following nasal
surgery. Our results show that PosiSep X causes lower levels of decrease in MEP in
the first 48 hours following surgery compared to silicone splint. Although it decreased
in the first 24 hours, we observed that the MEP in group P tended to increase to normal
values immediately afterwards. But our results show that the return to normal MEP
values in the splint group took up to 1 week following surgery. We think that this
is because PosiSep X causes lower levels of pressure in the nasal cavity, although
a silicone nasal splint with an integral airway enables nasal breathing.
Conclusion
Temporary aural fullness and ET dysfunction, which lead to patient discomfort and
dissatisfaction due to nasal packing after septoplasty, are a common problem. The
current study demonstrated that PosiSep X caused lower levels of ET dysfunction than
silicone nasal splint with integral airway. Moreover, PosiSep X does not require removal.
Therefore, we think it would be a good alternative for nasal packing after septoplasty.
Bibliographical Record
Halil Elden, Mahmut S. Yilmaz, Ahmet Cihan, Ebru M. Guven, Ahmet Kara. Effect of Chitosan-Based
Biodegradable Nasal Packs on Eustachian Dysfunction after Septoplasty. Int Arch Otorhinolaryngol
2025; 29: s00451809433.
DOI: 10.1055/s-0045-1809433
