The aim of this study was to investigate how fibrinogen-based collagen fleece (Tachocomb®) graft myringoplasty (FCGM), performed under microscopic guidance, improves both hearing and tympanic membrane tissue repair in patients with traumatic tympanic membrane perforation (TMP).
Between August 2009 and March 2015, a total of 52 patients with traumatic TMP visited the department of otorhinolaryngology at a secondary medical center. Twenty-nine of these underwent FCGM under microscopic guidance in our outpatient clinic. For each patient, we recorded the location and size of the perforation, the time elapsed from the onset of TMP until the myringoplasty, and the hearing level both before and after myringoplasty.
The TMP closed completely in all cases (29 of 29 patients). After myringoplasty, the postoperative air-bone gap (ABG) differed significantly from the preoperative ABG. Three of the 29 patients (10.3%) experienced complications. Specifically, 2 presented with otorrhea after FCGM, but conservative management led to improvement without recurrence of perforation. One patient showed delayed facial palsy 1 week after the procedure. The condition of this patient also improved and the palsy was not permanent.
FCGM may be an effective treatment option in case of traumatic TMP. The procedure requires no hospitalization, and can be used to avoid traditional tympanoplasty.
The tympanic membrane perforation (TMP) can be classified according to their duration, in acute and chronic (more than 3 months), and by the presence or absence of drainage, in wet and dry perforation [
The fibrinogen-based collagen fleece (Tachocomb®, Nycomed Austria GmbH, Linz, Austria) is a collagen-bound fibrinogen sealants. It consists of a sponge-like patch composed of equine collagen and coated with a mixture of human fibrinogen, bovine thrombin, and bovine aprotinin [
The aim of this study was to present the clinical outcomes of fibrinogen-based collagen fleece graft myringoplasty (FCGM) in traumatic TMP patients. The procedure was performed under microscopic guidance in our outpatient clinic.
Between August 2009 and March 2015, 52 patients with traumatic TMP visited the department of otorhinolaryngology at a secondary medical center. Of these, 29 underwent FCGM under microscopic guidance at the outpatient clinic. Ten patients were loss to follow-up after diagnosis of TMP, and 3 patients discontinued to visit the hospital after FCGM. Six patients were excluded because of the small TMP (less than 30% of the entire TM area), and 4 patients were young age (3-8 years old). For each patient, we recorded the location and size of perforation, the time elapsed from the onset of TMP until the myringoplasty, and the hearing level both before and after myringoplasty. There were 17 male and 12 female patients ranging in age from 13 to 69 years (mean age, 33.3±16.6 years). Indications for FCGM under microscopic guidance were as follows: patients 1) had a direct injury to the TM wherein the perforation area measured more than 30% of the entire TM area, and 2) the size of TMP was more than half of its original size after 2 weeks of observation. We also included patients in whom TMP had recurred despite their having undergone the paper patch procedure. All patients included in this study consented to participate in the study after hearing the merits and demerits of FCGM. We evaluated the patients using pure tone audiometry (PTA) both before the procedure and after the TMP had completely healed.
The surgical procedure, FCGM under microscopic guidance, was carried out as follows.
1) The external auditory canal (EAC) was cleaned and, along with the TM, locally anesthetized using a 10% lidocaine spray (Xylocaine® 10 mg spray, Astra Zeneca, Södertälje, Sweden). Ten minutes were allowed to pass between application of the spray and continuation of the surgery.
2) We divided the fibrinogen-based collagen fleece into pieces of about the size of the perforation, and one piece of about twice the size.
3) The TM was inspected, and the edge of the perforation was unfolded using the ear hook if necessary.
4) We inserted the smaller pieces of the fibrinogen-based collagen fleece into the middle ear cavity, and placed the larger piece onto the lateral side of TM (
PTA was performed before and after FCGM, and the frequencies 250, 500, 1,000, 2,000, and 4,000 Hz were used for analysis. The mean air-bone gap (ABG) was defined as the arithmetical average derived from the analysis of these frequencies. After the patch was removed and the TMP was examined the PTA measurements of each patient were recorded.
The data were analyzed using PASW® statistics 18 software (SPSS Inc., Chicago, IL, USA). The Wilcoxon signed rank test was used to compare the preoperative with the postoperative mean ABG, calculated from the PTA recordings.
This retrospective study was approved by the Institutional Review Board of Jeju National University Hospital for data collection and analysis (IRB No. JEJUNUH 2014-05-022). The requirement for informed consent was waived.
The location of the TM perforation was classified as anterior, central, posterior, or in multiple positions. Thirteen (44.8%) perforations occurred in the central position; 7 (24.1%) in the posterior position; 7 (24.1%) in the anterior position; and 2 (6.9%) in multiple positions. The average perforation area, expressed as a proportion of the entire TM, was 35.3±14.8%. The elapsed time between the onset of the TM perforation and the hospital visit ranged from 15 days to 12 months (57.0± 99.6 days).
In 19 patients (65.5%), the TM was perforated after others had slapped the face. Cotton swabs perforated the TM in a further 7 patients (24.1%), and 4 patients (13.8%) visited our hospital after failure of the paper patch procedure at another hospital.
The overall technical success rate was 100%. That is, all 29 patients showed complete healing of the TM. The complication rate was 10.3% (3 of 29 patients). Specifically, otorrhea occurred in 2 patients, but they improved without recurrence of perforation. One patient developed delayed facial palsy 1 week after the procedure, but the patient improved and no permanent facial palsy occurred. The mean follow-up period was 147.5±210.9 days (28-784 days,
When the postperative audiological outcomes in all patients were compared with the preoperative, there was significant difference with regard to the mean ABGs of patients (
Both the pars flaccida and the pars tensa of the TM consist of an epidermal layer, a lamina propria, and a mucosal epithelial layer. The fibrils of the fibrous layer contain a large amount of type II and type III collagens, and a small amount of type I collagen. It has been suggested that such an unusual collagen composition is the underlying reason for the unique physical features of the pars tensa of the TM [
Collagen type I and III are present in the acute healing phase after myringotomy and infection, and the collagen content of the TM is modified during the inflammatory and healing processes [
There was no control group in this study. However, the results of FCGM are better than those of conventional myringoplasty or paper patching in the literatures (overall success rate of 88.9-90.9%) [
In the follow-up visit, facial palsy (grade IV according to House-Brackmann facial nerve grading system) occurred in a patient 15 days after FCGM. Methylprednisolone was prescribed for 2 weeks and the patient recovered completely. Two patients had otorrhea after myringoplasty. Bacterial culture of otorrhea showed no growth, and otorrhea disappeared after using oral antibiotics (levofloxacin 250 mg twice a day) in both patients.
The main conclusion of this study is that FCGM may be a viable treatment option in cases of traumatic TMP. However, based on our results, we cannot say that the same procedure may be useful in cases of chronic otitis media. In a recent trial investigating the treatment of chronic and dry TMP, hyaluronic acid fat graft myringoplasty (HAFGM) was an effective technique for TMP treatment. The success rate of HAFGM in this trial was comparable to that of both the underlay and the overlay techniques [
In this study, we found that FCGM may be an effective treatment option in traumatic TMP. The postoperative ABG differed significantly from the preoperative. Furthermore, the technique requires no hospitalization, and can be used to avoid traditional tympanoplasty.
This work was supported by a research grant from Jeju National University Hospital.
No. of patient | Sex | Age (years) | Side | Location of TMP | Size of TMP (%) |
TMP to FCGM (days) | Duration of follow-up (days) | Causes of TMP | Previous history | Postoperative complication |
---|---|---|---|---|---|---|---|---|---|---|
1 | F | 69 | Rt | Central | 20 | 15 | 123 | Cotton swab | ||
2 | M | 24 | Lt | Central | 25 | 17 | 414 | Slap | ||
3 | F | 27 | Lt | Posterior | 40 | 23 | 93 | Slap | ||
4 | F | 33 | Lt | Anterior | 20 | 17 | 50 | Slap | ||
5 | M | 16 | Rt | Central | 20 | 20 | 29 | Slap | ||
6 | F | 54 | Lt | Anterior | 30 | 360 | 116 | Ear pulling | Tympanoplasty |
|
7 | F | 32 | Lt | Central | 30 | 66 | 63 | Cotton swab | Patch |
|
8 | M | 18 | Lt | Central | 80 | 62 | 30 | Slap | ||
9 | F | 49 | Lt | Central | 35 | 23 | 95 | Slap | ||
10 | F | 32 | Lt | Posterior | 25 | 19 | 56 | Slap | Patch‡ | |
11 | M | 16 | Lt | Posterior | 50 | 23 | 332 | Slap | ||
12 | F | 50 | Lt | Central | 30 | 20 | 28 | Cotton swab | ||
13 | M | 15 | Lt | Central | 40 | 22 | 28 | Slap | ||
14 | M | 27 | Lt | Central | 60 | 22 | 27 | Slap | Otorrhea | |
15 | M | 13 | Lt | Central | 35 | 24 | 22 | Slap | ||
16 | M | 59 | Lt | Central | 20 | 300 | 784 | Cotton swab | ||
17 | F | 38 | Lt | Central | 40 | 20 | 89 | Slap | Otorrhea | |
18 | M | 64 | Lt | Multiple | 30 | 24 | 28 | Slap | ||
19 | M | 45 | Lt | Anterior | 30 | 17 | 129 | Barotrauma |
||
20 | M | 22 | Rt | Anterior | 30 | 21 | 880 | Swimming | ||
21 | M | 39 | Lt | Anterior | 25 | 365 | 260 | Slap | ||
22 | M | 18 | Lt | Anterior | 30 | 15 | 62 | Slap | Patch‡ | |
23 | M | 29 | Lt | Central | 60 | 15 | 89 | Slap | ||
24 | F | 55 | Lt | Posterior | 20 | 30 | 34 | Slap | ||
25 | M | 38 | Lt | Anterior | 40 | 23 | 131 | Cotton swab | ||
26 | F | 17 | Rt | Posterior | 40 | 22 | 106 | Cotton swab | ||
27 | F | 38 | Rt | Posterior | 20 | 23 | 63 | Cotton swab | ||
28 | M | 13 | Lt | Posterior | 40 | 22 | 50 | Slap | Patch‡ | Facial nerve palsy |
29 | M | 15 | Lt | Multiple | 60 | 22 | 65 | Slap |
TMP: tympanic membrane perforation, FCGM: fibrinogen-based collagen fleece graft myringoplasty, F: female, M: male, Rt: right, Lt: left
the size of TMP was measured when patients underwent FCGM under microscopic guidance,
the patient has history of the tympanoplasty operation in another hospital,
the patient has history of the paper patch procedure in another hospital,
barotrauma during the flight have made the TMP to the patient.
Author, year | Country | Model | TMP duration | Cause of TMP | Patch material (patients number) | Control group | Assessment methods | Result |
---|---|---|---|---|---|---|---|---|
Lee, et al., 2008 [ |
South Korea | Human | Chronic | COM | Paper patch after trimming with C02 laser (90) | None | Endoscopy, audiometry | Healing rate (%): 52.2 |
Improvement of ABG in all the cases where the TM healed to normal status | ||||||||
Hakuba, et al., 2010 [ |
Japan | Human | Chronic | COM | Silicone film with bFGF and atelocollagen (87) | None | Endoscopy, audiometry | Healing rate (%): 92 |
Hearing threshold improvement by 10 dB or more in 51 patients, 13.4 dB HL of average hearing improvement | ||||||||
Lou and He, 2011 [ |
China | Human | Acute, ≤ 3 days | Trauma | Gelfoam patch (30), Perforation edge-approximation with gelfoam patch (30) | No treatment | Endoscopy, healing time, infection rate | Healing rate (%): 97, 97 (study groups), 85 (control group) ( |
Healing time (days): 16±5.6, 18±4.7 (study groups) & 30±10.1 (control group) ( |
||||||||
Infection rate (%): 3, 3 (study groups), 7 (control group) | ||||||||
Saliba and Woods, 2011 [ |
Canada | Human | Chronic, > 6 months | COM | Hyaluronic acid fat graft myringoplasty (131) | Underlay technique with TF/TP, overlay technique with TF/TP | Endoscopy, audiometry | Healing rate (%): 92.7 (study groups), 92.2 & 92.6 (control groups) ( |
ABG (dB HL): clinically and statistically significant improvement in hyaluronic acid fat graft myringoplasty | ||||||||
Araujo, et al., 2012 [ |
Brazil | Human | Chronic | COM | Myringoplasty with polylysine latex biomembrane (39) | Myringoplasty only, myringoplasty with silicone film | Endoscopy, audiometry | Healing rate (%): 74.4 (study group), 70 & 57.1 (control groups) ( |
Vascularization: significantly greater in myringoplasty with polylysine latex biomembrane | ||||||||
ABG (dB HL): 23.5 → 12.9 |
||||||||
Jun, et al., 2014 [ |
South Korea | Human | Acute, ≤ 3 months | Trauma | Egg shell membrane (39) | Perforation edge-approximation | Endoscopy, healing time | Healing rate (%): 92.3 (study group), 89.7 (control group) ( |
Healing time (days): 42.8±19.8 (study group), 87.2±41.3 (control group) ( |
||||||||
Simsek and Akin, 2014 [ |
Turkey | Human | Acute, ≤10 days | Trauma | Paper patch (33) | No treatment | Endoscopy, audiometry | Healing rate (%): 90.9 (study group), 76.7 (control group) ( |
ABG (dB HL): 23.6 → 1 |
||||||||
Present study | South Korea | Human | Acute & chronic, > 14 days | Trauma | Fibrinogen-based collagen fleece (29) | None P" | Endoscopy, audiometry | Healing rate (%): 100 |
ABG (dB HL): 12.9 → 2.4 |
preoperative average ABG → postoperative average ABG.
TMP: tympanic membrane perforation, COM: chronic otitis media, ABG: air-bone gap, TM: tympanic membrane, TF: temporalis fascia, TP: tragal perichondrium, bFGF: basic fibroblast growth factor