Abstract
Objective
The aim of this study was to evaluate the effectiveness of basic fibroblast growth factor (bFGF) treatment on traumatic perforation of the tympanic membrane at different time points.
Research Design
This is a prospective clinical study.
Methods
Patients with traumatic perforations of the tympanic membrane were given a treatment of gelatin sponge + bFGF at different time intervals of 3 days, 4 to 7 days, 8 to 15 days, and more than 4 weeks after the injury. Healing rate and time of perforation were also observed after 1 month.
Results
In 147 ears, 144 (98.0%) were healed. The perforation healing rates were 98.6%, 97.6%, 96.3%, and 100%, respectively, at the following time intervals: within 3 days, 4 to 7 days, 8 to 14 days, and 2 to 4 weeks since the injury. This was quite true without any significant difference ( P > .05). Meanwhile, in the small perforation healing of 120 ears, the average healing times from admission to perforation within 3 days, 4 to 7 days, and 8 to 14 days after the injury were 7.95 ± 2.07, 6.75 ± 2.67, and 4.18 ± 0.91 days, respectively. No significant difference was found among the 3 groups ( P 1 < .01).
Conclusion
Treating traumatic perforation of the tympanic membrane using the bFGF technique at different times of admissions is quite effective.
1
Introduction
The tympanic membrane is very sensitive to the pressure changes of the external auditory canal. Explosion wound, palm boxing injury, and so on, usually result in acute perforation of the tympanic membrane, resulting in middle ear infection and conductive deafness . Traumatic perforation of the tympanic membrane can be healed naturally, but the average time of healing extends from 4 to 6 weeks . Clinical evidence has proven that basic fibroblast growth factor (bFGF) increases the healing rate of traumatic perforation of the tympanic membrane, shortening its healing time . However, Chauvin et al reckon that there is a certain critical time window in bFGF treatment of acute perforation of the tympanic membrane. The purpose of this study is to evaluate the effectiveness of bFGF treatment on traumatic perforation of the tympanic membrane at different time points.
2
Materials and methods
China’s Yiwu is the largest small commodity-distributing center in Asia, with a population of 180 million people. Yiwu Central Hospital is the only center for ENT treatment and emergency. In this research study, patients with traumatic perforation of the tympanic membrane were selected, provided that they met the following criteria: (1) no previous disease of middle ear and (2) patients consulted within 3 months since they experienced the perforation. The period during which this research study was conducted extended from January 2010 to December 2011. The relative size of perforation was determined according to the following criteria under otoscope: small, less than one fourth of the area of membrana tensa, and larger, at least one fourth of the area of membrana tensa. One hundred forty-seven ears of patients meeting the above criteria were selected. This study was conducted on 51 male and 96 female patients from 5 to 56 years of age (mean ± SD, 32.1 ± 1.9 years). The consultation period varied from 3 hours to 2 months. In 147 ears, 17 were damaged owing to a firecracker blast injury; 105 were damaged owing to a palm boxing injury; 9 were damaged owing to a basketball injury; 7 with a pressed ear canal were damaged when shampooing; and 9 diagnosed as having external auditory canal injury were damaged by a cotton swab, a pencil, and so on. Moreover, 136 ears were diagnosed as having dry perforation of the tympanic membrane, whereas 11 ears were diagnosed as having secondary water or bloody otorrhea. There were 26 ears with a large perforation and 121 ears with a small perforation. The standard pure tone hearing test was performed, and the average pure tone of airborne gap was calculated at frequencies of 500, 1000, 2000, and 4000 Hz. One hundred forty-seven ears were treated with a technique using gelatin sponge patch + fibroblast growth factor: they were treated only after obtaining informed consent from the patients. Moreover, the research was approved and agreed on by the ethics committee of Yiwu Central Hospital. Research funds were sponsored by Zhejiang Science and Technology Foundation.
The external ear canal cerumen was cleaned and sterilized with 1% povidone-iodine solution. The gelatin sponge, slightly larger than the perforation, was affixed to the perforated surface. One to 2 drops of bFGF eye drops were used locally twice a day to keep the gelatin sponge moist. External auditory canal otorrhea was avoided. Chemicals such as silver nitrate and aural microsurgery equipment were not used in patients who reported an injury to the tympanic membrane perforation within 4 weeks. Patients who were diagnosed as having secondary purulent otorrhea were prescribed oral antibiotics for a period of 1 to 2 weeks. These patients were also asked to avoid an entry of water into their ears. The perforation was examined by otoscope at least 2 times a week, and its healing was confirmed by otoscope and acoustic immittance tests. After the perforation healing, pure tone hearing test was repeated. There were 2 ways to evaluate the healing time of perforation: (1) obtaining the time from treatment to perforation healing (T1) and (2) obtaining the time from injury to perforation healing (T2). The therapeutic effectiveness was analyzed using SPSS version 11.0 computer software (SPSS, Chicago, IL), a paired t test, and a variance test to compare the time and rate of perforation healing, respectively. One-way analysis of variance was applied for multisample mean comparison between the groups, and P < .05 was considered statistically significant.
2
Materials and methods
China’s Yiwu is the largest small commodity-distributing center in Asia, with a population of 180 million people. Yiwu Central Hospital is the only center for ENT treatment and emergency. In this research study, patients with traumatic perforation of the tympanic membrane were selected, provided that they met the following criteria: (1) no previous disease of middle ear and (2) patients consulted within 3 months since they experienced the perforation. The period during which this research study was conducted extended from January 2010 to December 2011. The relative size of perforation was determined according to the following criteria under otoscope: small, less than one fourth of the area of membrana tensa, and larger, at least one fourth of the area of membrana tensa. One hundred forty-seven ears of patients meeting the above criteria were selected. This study was conducted on 51 male and 96 female patients from 5 to 56 years of age (mean ± SD, 32.1 ± 1.9 years). The consultation period varied from 3 hours to 2 months. In 147 ears, 17 were damaged owing to a firecracker blast injury; 105 were damaged owing to a palm boxing injury; 9 were damaged owing to a basketball injury; 7 with a pressed ear canal were damaged when shampooing; and 9 diagnosed as having external auditory canal injury were damaged by a cotton swab, a pencil, and so on. Moreover, 136 ears were diagnosed as having dry perforation of the tympanic membrane, whereas 11 ears were diagnosed as having secondary water or bloody otorrhea. There were 26 ears with a large perforation and 121 ears with a small perforation. The standard pure tone hearing test was performed, and the average pure tone of airborne gap was calculated at frequencies of 500, 1000, 2000, and 4000 Hz. One hundred forty-seven ears were treated with a technique using gelatin sponge patch + fibroblast growth factor: they were treated only after obtaining informed consent from the patients. Moreover, the research was approved and agreed on by the ethics committee of Yiwu Central Hospital. Research funds were sponsored by Zhejiang Science and Technology Foundation.
The external ear canal cerumen was cleaned and sterilized with 1% povidone-iodine solution. The gelatin sponge, slightly larger than the perforation, was affixed to the perforated surface. One to 2 drops of bFGF eye drops were used locally twice a day to keep the gelatin sponge moist. External auditory canal otorrhea was avoided. Chemicals such as silver nitrate and aural microsurgery equipment were not used in patients who reported an injury to the tympanic membrane perforation within 4 weeks. Patients who were diagnosed as having secondary purulent otorrhea were prescribed oral antibiotics for a period of 1 to 2 weeks. These patients were also asked to avoid an entry of water into their ears. The perforation was examined by otoscope at least 2 times a week, and its healing was confirmed by otoscope and acoustic immittance tests. After the perforation healing, pure tone hearing test was repeated. There were 2 ways to evaluate the healing time of perforation: (1) obtaining the time from treatment to perforation healing (T1) and (2) obtaining the time from injury to perforation healing (T2). The therapeutic effectiveness was analyzed using SPSS version 11.0 computer software (SPSS, Chicago, IL), a paired t test, and a variance test to compare the time and rate of perforation healing, respectively. One-way analysis of variance was applied for multisample mean comparison between the groups, and P < .05 was considered statistically significant.
3
Results
3.1
The healing of perforation
Of the 147 ears, 144 (98.0%) were healed within 1 month. Among them, 121 ears had small perforations, and 120 ears (99.2%) were healed. The perforation healing rates were 98.2%, 100%, 100%, and 100%, respectively, when these ears were examined at the following time intervals: 3 days, 4 to 7 days, 8 to 14 days, and 2 to 4 weeks during the course of treatment. Furthermore, statistical analysis also did not show significant differences ( P > .05). Table 1 shows the mean of T1 and T2. The comparison among the first 3 groups showed that the average healing time was shortest in patients who were admitted within 8 to 14 days since experience of perforations (F 1 = 24.85, P 1 < .01). In case of admissions within 3 days after perforation, the average healing time of T2 was the shortest. Using pairwise comparisons with the Student-Newman-Keuls method, the results of the first 3 groups in T1 and T2 were all significant ( P 1 < .01). Two ears were treated at 8 weeks, and the scab of 1 ear was healed. The perforation was cured 6 days after clearance of the crust was achieved using the gelatin sponge + bFGF technique. On the other hand, the other ears were healed 3 days later, and the morphotype of the healed tympanic membrane was normal. Of the 26 ears that were diagnosed as having large perforation, 24 (92.3%) were healed. Table 2 illustrates the healing rate and time of perforation for patients who consulted within 3, 4 to 7, and 8 to 14 days since the injury. The average T1’s were 13.14 ± 1.16, 11.4 ± 3.13, and 10.5 ± 3.11 days, whereas the average T2’s were 14.57 ± 1.02, 17.6 ± 3.05, and 21 ± 2.16 days, respectively, for the 3 categories of patients. The morpha of the tympanic membrane was examined under the otoscope.
