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Topical use of autologous platelet rich plasma in myringoplasty
Auris Nasus Larynx 42 (2015) 365–368
Contents lists available at ScienceDirect
Auris Nasus Larynx journal homepage: www.elsevier.com/locate/anl
Topical use of autologous platelet rich plasma in myringoplasty Mohammad Waheed El-Anwar a,*, Magdy Abdalla Sayed El-Ahl a, Amal Ahmad Zidan b, Mohammad Abdel-Rhman Abdel-Salam Yacoup a a b
Otorhinolaryngology, Head and Neck Surgery Department, Faculty of Medicine, Zagazig University, Egypt Clinical Pathology Department, Faculty of Medicine, Zagazig University, Egypt
A R T I C L E I N F O
A B S T R A C T
Article history: Received 18 November 2014 Accepted 19 February 2015 Available online 17 March 2015
Objective: The aim of this study was to assess the topical use of autologous platelet rich plasma (PRP) to improve success rate of myringoplasty. Methods: This study was carried out on 64 patients with large dry central tympanic membrane perforations. Myringoplasty was performed through postauricular approach by underlay graft using conchal perichondrial graft. Patients were classified into two groups: case group included 32 patients who had undergone myringoplasty with use of autologous PRP and control group included 32 patients who had undergone myringoplasty without use of autologous PRP. Results: Both groups were statistically matched with regard to age and sex. At 6 months postoperatively, success rate (graft taking) in case group (100%) was significantly higher than in control group (81.25%) (P = 0.02). Success in terms of hearing gain (10 dB) was achieved in 21 patients (65.6%) in case group and 11 patients (34.4%) in control group with statistically non-significant difference (P = 0.079). Infection rate in control group (12.5%) was found to be significantly higher than in case group (P < 0.0001). Conclusion: Topical autologous PRP application during myringolpasty is safe and highly efficient and successful with no reported complication. PRP not only enhances healing of chronic TM perforations but also avoids infection and obviates the need for inner EAC pack. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Myringoplasty Platelet rich plasma Tympanic membrane
1. Introduction As reported in literature, the success rate after myringoplasty has a wide range and failure rate after myringoplasty may reach 22 [1] or more % [2] and up to 40% in adults and even up to 65% in children [3]. Therfore there is still a need to search for methods to enhance tympanic membrane (TM)) healing after myringoplasty to increase success rate. Platelet rich plasma (PRP) represents an emerging biotechnology in current tissue engineering and cellular therapy [4,5], it is a simple and minimally invasive method to obtain a high concentrate of autologous growth factors (GFs), which can be easily and safely placed directly into the lesion site [6]. Erkilet et al. [7] suggested that autologous PRP is effective in accelerating TM perforation healing in rats, so it needs to be investigated in myringoplasty in human subjects, particularly as it is an autologous material.
* Corresponding author at: Otorhinolaryngology, Head and Neck Surgery Department, Faculty of Medicine, Zagazig University, Egypt. Tel.: +20 1004695197. E-mail address: [email protected] (M.W. El-Anwar). http://dx.doi.org/10.1016/j.anl.2015.02.016 0385-8146/ß 2015 Elsevier Ireland Ltd. All rights reserved.
The aim of this study was to assess the topical use of autologous PRP to improve success rate of myringoplasty. 2. Patients and methods This randomized controlled trial was carried out on 64 patients with central large TM perforations caused by tubotympanic chronic suppurative otitis media (CSOM) for whom myringoplasty was performed in the period from October 2012 to April 2014. This study was approved by the institutional review board (IRB) at Zagazig University Hospitals and informed written consent was obtained from the patients or parents of the enrolled children. All patients were subjected to full history taking, clinical examination, laboratory testing and pure tone audiometry. All patients had dry central TM perforation and apparently healthy middle ear mucosa at least for 3 months before surgery and hearing level corresponds to the size and site of the perforation (no suspicion of ossicular chain defect or other pathology). Patients present with active ear discharge, cholesteatoma, patients who underwent any type of mastoidectomy and those with suspected ossicular pathology having more than 40 dB air bone gap (ABG) were excluded.
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M.W. El-Anwar et al. / Auris Nasus Larynx 42 (2015) 365–368
Fig. 1. PRP preparation and insertion: (A) blood was separated out into the three layers; the middle layer contains the PRP. (B) PRP could be easily obtained. (C) Insertion of autologous PRP (arrow) in external auditory canal after adjustment of the graft.
The TM was divided preoperatively into four quadrants as used by Saliba [8] so included large perforation involve more than two quadrants and not total. Myringoplasty was done using underlay technique under general anesthesia in all cases. Post auricular approach was used and the concheal perichondrium graft was harvested for all cases. Patients were classified into two groups: case group included 32 patients who had undergone myringoplasty with use of autologous PRP and control group included 32 patients who had undergone myringoplasty without use of autologous PRP. 2.1. Preparation of the autologous PRP During induction of anesthesia and first steps of surgery and under sterile technique, 5 ml of peripheral venous blood was drawn from the patient with a 16 or 18 gauge butterfly needle or syringe to avoid irritation and damage of the platelets; then collected blood was kept in a 5 ml plain vacuum tubes (without an anticoagulant or calcium), and then the tubes were immediately centrifuged using a tabletop centrifuge (Zhengji 800-centrifuge, china) machine for 12 min at 3200 rpm and finally the temperature of the centrifugation was kept operative at room temperature. So blood was separated out into the three layers owing to the density of its inner contents [9]: the bottom layer consists of red blood cells, the middle layer contains PRP (about 1.5 ml3), which is composed of platelets and white blood cells (WBCs; buffy coat) that could be easily obtained and the top layer contains platelet poor plasma (Fig. 1A and B). The PRP layer was taken out at time of use. In group A: after placing and adjusting the graft in its place and replacing the posterior tympanomeatal flap to its position, the autologous PRP was inserted (as a plug) into external auditory canal (EAC) on the lateral surface of the graft and TM remnant (Fig. 1C). In group B: Gelfoam was inserted on the lateral surface of the graft and TM remnant in EAC. In both groups, only an outer EAC pack was left. Pressure dressing was left over the operated ear for 1 week. Patients were discharged in the same day of surgery. Broad spectrum systemic antibiotic was described for 1 week. The patients in this study were evaluated on the basis of postoperative graft taking, hearing improvement and complications. Successful closure of perforation was defined as an intact TM at 6 months postoperatively. Success in terms of hearing was defined as an improvement of 10 dB or greater at 6 months as used by Sergi et al. [10]. 2.2. Statistical analysis Statistical analyses were performed using SPSS 17 statistical software for Windows (SPSS Inc., Chicago, IL). The significance level was set at P < 0.05. Quantities data in patient and control groups
were compared using a t test. Categorical variables were compared with a chi-square test for sex and Fisher’s exact test was used for other outcome results. 3. Results Sixty-four patients who had large central dry TM perforation were included in this study, which constituted 8 males (25%) and 24 females (75%) in case group and 9 males (28.1%) and 23 females (71.9%) in control group with non-significant difference (P = 0.777). The mean age (SD) was 22.9 (9.16) for case group and 19.9 (14.11) for control group with also non-significant difference (P = 0.4588) (Table 1). The follow-up ranged from 6 to 16 months. At 6 months postoperatively, success rate (graft taking) in case group (100%) was significantly higher than in control group (81.25%) (P = 0.02). While no residual perforation was reported in case group, 6 cases (18.75%) showed residual perforation in control group. Success in terms of hearing gain (10 dB) revealed that in case group, success was achieved in 21 patients (65.6%) that is better than the success achieved in control group (11 patients, 34.4%) with non-quite statistically significant difference (P = 0.079). When comparing the success in terms of hearing gain (10 dB) in graft taken case only, the difference was found to be non-significant (P = 0.288) (Table 2). So the difference in hearing success related to closure of TM perforation. Preoperative mean (SD) of air bone gab (ABG) in group A was 23 (3.83) and in group B was 22.34 (8.33) with non-significant difference (P = 0.6852). While postoperative mean (SD) of ABG was 12.5 7.64 in group A and 14.91 7.23 without statistically significant difference (P = 0.1998). The mean (SD) hearing gain was 10.5 dB (6.97) and 7.43 dB (7.7) for group A and group B, respectively, with non-significant difference (Table 3). No graft was lateralized or displaced into the middle ear and no retraction pocket was observed during the follow-up period. There Table 1 Comparison between the studied groups regarding age and sex. Study groups
Case group
Control group
Variants
No.
%
No.
%
Patients Sex Male Female Age (years) Mean Range
32
100
32
100
8 24
25 75
9 23
NS, non-significant. * Chi-square test. ** Student’s t test.
22.8 9.2 12–45
28.1 71.9 20.9 11.1 12–48
P value
0.777* NS
0.4588** NS
M.W. El-Anwar et al. / Auris Nasus Larynx 42 (2015) 365–368 Table 2 Success rates according to graft take and hearing gain. Study groups
Case group
Variants
Number
Control group Percent (%)
Graft taking Success 32 100 0 0 Failure Hearing success in all cases 10 dB (success) 21 65.6 <10 dB (failure) 11 34.4 Hearing success in graft taken cases 10 dB (success) 21 65.6 <10 dB (failure) 11 34.4
P value
Number
Percent (%)
26 6
81.25 18.75
0.02* S
13 19
40.6 59.4
0.079* NS
13 13
50 50
0.288* NS
NS, non-significant; S, significant. * Fisher’s exact test.
Table 3 Air bone gab (ABG) and mean hearing gain results. Group A Preoperative ABG (mean SD) Postoperative ABG (mean SD) Mean hearing gain
Group B
P value
23 dB 3.83
22.34 dB 8.33
12.5 dB 7.64
14.91 dB 7.23
10.5 dB 6.97
7.43 dB 7.7
0.6852** NS (t = 0.4072) 0.1998** NS (t = 1.2961) 0.0995** NS (t = 1.6721)
NS, non-significant. ** Non-paired t test.
were no postoperaive complications such as SNHL, tympanosclerosis or thin atrophic areas. No infection was detected in case group but in control group there were four cases who had postoperative otorrhea caused by middle ear infection on top of residual perforation that were controlled by medical treatment, this infection rate in control group (12.5%) was significantly higher than in case group (P < 0.0001).
4. Discussion Myringoplasty is a reconstructive operation of the TM performed to prevent recurrent ear discharge and to improve hearing impairment caused by TM perforation [2,11]. PRP as a carrier of growth factors accelerates endothelial, epithelial, and epidermal regeneration, stimulates angiogenesis, enhances collagen synthesis and soft tissue healing, decreases dermal scarring, and promotes the hemostatic response to injury [12]. The autologous PRP is simple and easy to be prepared with no reported side effects [13]. Erkilet et al. [7] suggested that autologous PRP is effective in accelerating TM perforation healing in rats. This encourages us to try it in myringoplasty in large TM perforation in human, particularly as it is an autologous material. In current study, the graft take rate was perfect in all cases (100% success rate) with the use of PRP with significant higher take rate than without PRP use with no reported complication including infection that was reported to be significantly higher in control group. These results prove the role of autologous PRP in enhancing healing of TM even in large perforation. In addition, PRP as prepared in current study has a significant role against infection. This is not consistent with Bielecki et al. [14] and Tate and Crane [15] who reported that the presence of WBCs in high concentrations in PRP makes it act as bacteriocidal. No effect of PRP use on hearing gain in graft taked cases because hearing gain related to closure of TM.
367
Our method is supposed to be safe with no fear of SNHL as PRP has no side effects and we use a simple method that does not use any additives such as anticoagulants or calcium. Also the use of autologous PRP had may advantages like it is safe (from patient’s blood no fear of infecious diseases), rapid (in 12 min) and easy to be prepared begin during induction of anesthesia and ready before step of its application so its preparation is not a burden on the length of surgery, low relative cost (syring and vacuum tube), no use of additives (no anticoagulant or any toxic materials) and it guards against infection. PRP was reported to aid in the initial stability of the grafted tissue at the recipient sites (as a result of its cohesive and adhesive nature). PRP may promote faster vascularization of the healing tissue by delivering growth factors that induce regeneration. Due to super saturation of the wound with PRP, growth factors fasten tissue regeneration [16]. It is easy to handle and apply PRP even easier than Gelfoam. The natural acceleration of patient healing achieved with PRP had been proven to be inherently safe. The PRP graft is derived from autologous blood drawn at the time of treatment. Any allergic potential would be due to additive agents (such as local anesthetics employed for patient comfort at the time of injection) [14,15] that were not needed in our study because the patient was under general anesthesia. The autologous nature of the sample also eliminates concern over disease transfer. It had also been shown that due to the presence of WBCs, PRP grafts are bactericidal [14,15]. The in vivo half-life time of platelets is about 7–10 days [17] that is a suitable duration for healing of the TM peroration with the enhancing effect of PRP. Beside the main role of autologous PRP GFs in healing, we depended on autologous PRP to provide protection to the operated site, hold the graft in situ and prevent sagging of the posterior canal wall instead of inner EAC pack avoiding pack complication as hypersensitivity reaction of variable degree, canal granulation, stenosis or discharge [18,19]. This is the first clinical study of topical application of autologous PRP during repair of large TM perforation caused by CSOM and proved to have a significant beneficial effect on healing. So topical autologous PRP application during myringolpasty is safe and highly efficient and successful. Autologous PRP not only enhances healing of chronic TM perforations but also avoids infection and obviates the need for inner EAC pack. Therefore, it is recommended to regularly use topical autologous PRP during myringoplasty and further studies are needed to be investigated its healing effect in patients who had well known healing compromise as with diabetes mellitus. Healing effect of autologous PRP, at the cellular level, on different layers of the TM is also need to be studied. 5. Conclusion Topical autologous PRP application during myringolpasty is safe and highly efficient and successful with no reported complication. Autologous PRP not only enhances healing of chronic TM perforations but also avoids infection and obviates need for inner EAC pack. Financial support The authors declare no financial support or interest to this study. Conflict of interest The authors declare no conflict of interest.
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References [1] Nardone M, Sommerville R, Bowman J, Danesi G. Myringoplasty in simple chronic otitis media: critical analysis of long-term results in a 1,000-adult patient series. Otol Neurotol 2012;33:48–53. [2] Al-Khtoum N, Hiari MA. Myringoplasty in children: retrospective analysis of 35 cases. Braz J Otorhinolaryngol 2009;75:371–4. [3] Sarkar S, Roychoudhury A, Roychaudhuri BK. Tympanoplasty in children. Eur Arch Otorhinolaryngol 2009;266:627–33. [4] Jameson CA. Autologous platelets concentrate for the production of platelet gel. Lab Med 2007;38:39–42. [5] Mazzucco L, Balbo V, Cattana E, Borzini P. Platelet-rich plasma and platelet gel preparation using Plateltex. Vox Sang 2008;94:202–8. [6] Creaney L, Hamilton B. Growth factor delivery methods in the management of sports injuries: the state of play. Br J Sports Med 2008;42:314–20. [7] Erkilet E, Koyuncu M, Atmaca S, Yarim M. Platelet-rich plasma improves healing of tympanic membrane perforations: experimental study. J Laryngol Otol 2009;123:482–7. [8] Saliba I. Hyaluronic acid fat graft myringoplasty: how we do it. J Compil Clin Otolaryngol 2008;33:607–28. [9] Welsh WJ. Autologous platelet gel – clinical function and usage in plastic surgery. Cosmetic Dermatol 2000;11:13–8. [10] Sergi B, Galli J, De Corso E, Parrilla C, Paludetti G. Overlay versus underlay myringoplasty: report of outcomes considering closure of perforation and hearing function. Acta Otorhinolaryngol Ital 2011;31:366–71.
[11] Akayleh R, Alroosan M. The surgical outcome of myringoplasty in adults in the Royal Medical Services Amman-Jordon. Khartoum Med J 2012;5:816–8. [12] Smith RG, Gassmann CJ, Campbell MS. Platelet-rich plasma: properties and clinical applications. J Lanc Gen Hosp 2007;2:73–7. [13] Salaheldin AH, Hussein A. Effect of platelet-rich plasma on nasal mucociliary clearance after submucous diathermy of inferior turbinate. Egypt J Ear Nose Throat Allied Sci 2012;13:71–5. [14] Bielecki TM, Gazdzik TS, Arendt J, Szczepanski T, Kro´l W, Wielkoszynski T. Antibacterial effect of autologous platelet gel enriched with growth factors and other active substances: an in vitro study. J Bone Joint Surg 2007;89:417–20. [15] Tate KS, Crane DM. Platelet rich plasma grafts in musculoskeletal medicine. J Prolother 2010;2:371–6. [16] Kaur P. Platelet-rich plasma: a novel bioengineering concept. Trends Biomater Artif Organs 2011;25:86–90. [17] Everts PA, Knape JT, Weibrich G, Scho¨nberger JP, Hoffmann J, Overdevest EP, et al. Platelet-rich plasma and platelet gel: a review. J Extra Corpor Technol 2006;38:174–87. [18] Anderson O, Takwoingi YM. Tri-adcortyl ointment ear dressing in myringoplasty: an analysis of outcome. Eur Arch Otorhinolaryngol 2007;264: 873–7. [19] Alsanosi A. Myringoplasty: a comparison of bismuth iodoform paraffin paste gauze pack and plane gauze (containing lococotien with veoform). Int J Health Sci Qassim Univ 2009;3:29–31.
Contents lists available at ScienceDirect
Auris Nasus Larynx journal homepage: www.elsevier.com/locate/anl
Topical use of autologous platelet rich plasma in myringoplasty Mohammad Waheed El-Anwar a,*, Magdy Abdalla Sayed El-Ahl a, Amal Ahmad Zidan b, Mohammad Abdel-Rhman Abdel-Salam Yacoup a a b
Otorhinolaryngology, Head and Neck Surgery Department, Faculty of Medicine, Zagazig University, Egypt Clinical Pathology Department, Faculty of Medicine, Zagazig University, Egypt
A R T I C L E I N F O
A B S T R A C T
Article history: Received 18 November 2014 Accepted 19 February 2015 Available online 17 March 2015
Objective: The aim of this study was to assess the topical use of autologous platelet rich plasma (PRP) to improve success rate of myringoplasty. Methods: This study was carried out on 64 patients with large dry central tympanic membrane perforations. Myringoplasty was performed through postauricular approach by underlay graft using conchal perichondrial graft. Patients were classified into two groups: case group included 32 patients who had undergone myringoplasty with use of autologous PRP and control group included 32 patients who had undergone myringoplasty without use of autologous PRP. Results: Both groups were statistically matched with regard to age and sex. At 6 months postoperatively, success rate (graft taking) in case group (100%) was significantly higher than in control group (81.25%) (P = 0.02). Success in terms of hearing gain (10 dB) was achieved in 21 patients (65.6%) in case group and 11 patients (34.4%) in control group with statistically non-significant difference (P = 0.079). Infection rate in control group (12.5%) was found to be significantly higher than in case group (P < 0.0001). Conclusion: Topical autologous PRP application during myringolpasty is safe and highly efficient and successful with no reported complication. PRP not only enhances healing of chronic TM perforations but also avoids infection and obviates the need for inner EAC pack. ß 2015 Elsevier Ireland Ltd. All rights reserved.
Keywords: Myringoplasty Platelet rich plasma Tympanic membrane
1. Introduction As reported in literature, the success rate after myringoplasty has a wide range and failure rate after myringoplasty may reach 22 [1] or more % [2] and up to 40% in adults and even up to 65% in children [3]. Therfore there is still a need to search for methods to enhance tympanic membrane (TM)) healing after myringoplasty to increase success rate. Platelet rich plasma (PRP) represents an emerging biotechnology in current tissue engineering and cellular therapy [4,5], it is a simple and minimally invasive method to obtain a high concentrate of autologous growth factors (GFs), which can be easily and safely placed directly into the lesion site [6]. Erkilet et al. [7] suggested that autologous PRP is effective in accelerating TM perforation healing in rats, so it needs to be investigated in myringoplasty in human subjects, particularly as it is an autologous material.
* Corresponding author at: Otorhinolaryngology, Head and Neck Surgery Department, Faculty of Medicine, Zagazig University, Egypt. Tel.: +20 1004695197. E-mail address: [email protected] (M.W. El-Anwar). http://dx.doi.org/10.1016/j.anl.2015.02.016 0385-8146/ß 2015 Elsevier Ireland Ltd. All rights reserved.
The aim of this study was to assess the topical use of autologous PRP to improve success rate of myringoplasty. 2. Patients and methods This randomized controlled trial was carried out on 64 patients with central large TM perforations caused by tubotympanic chronic suppurative otitis media (CSOM) for whom myringoplasty was performed in the period from October 2012 to April 2014. This study was approved by the institutional review board (IRB) at Zagazig University Hospitals and informed written consent was obtained from the patients or parents of the enrolled children. All patients were subjected to full history taking, clinical examination, laboratory testing and pure tone audiometry. All patients had dry central TM perforation and apparently healthy middle ear mucosa at least for 3 months before surgery and hearing level corresponds to the size and site of the perforation (no suspicion of ossicular chain defect or other pathology). Patients present with active ear discharge, cholesteatoma, patients who underwent any type of mastoidectomy and those with suspected ossicular pathology having more than 40 dB air bone gap (ABG) were excluded.
366
M.W. El-Anwar et al. / Auris Nasus Larynx 42 (2015) 365–368
Fig. 1. PRP preparation and insertion: (A) blood was separated out into the three layers; the middle layer contains the PRP. (B) PRP could be easily obtained. (C) Insertion of autologous PRP (arrow) in external auditory canal after adjustment of the graft.
The TM was divided preoperatively into four quadrants as used by Saliba [8] so included large perforation involve more than two quadrants and not total. Myringoplasty was done using underlay technique under general anesthesia in all cases. Post auricular approach was used and the concheal perichondrium graft was harvested for all cases. Patients were classified into two groups: case group included 32 patients who had undergone myringoplasty with use of autologous PRP and control group included 32 patients who had undergone myringoplasty without use of autologous PRP. 2.1. Preparation of the autologous PRP During induction of anesthesia and first steps of surgery and under sterile technique, 5 ml of peripheral venous blood was drawn from the patient with a 16 or 18 gauge butterfly needle or syringe to avoid irritation and damage of the platelets; then collected blood was kept in a 5 ml plain vacuum tubes (without an anticoagulant or calcium), and then the tubes were immediately centrifuged using a tabletop centrifuge (Zhengji 800-centrifuge, china) machine for 12 min at 3200 rpm and finally the temperature of the centrifugation was kept operative at room temperature. So blood was separated out into the three layers owing to the density of its inner contents [9]: the bottom layer consists of red blood cells, the middle layer contains PRP (about 1.5 ml3), which is composed of platelets and white blood cells (WBCs; buffy coat) that could be easily obtained and the top layer contains platelet poor plasma (Fig. 1A and B). The PRP layer was taken out at time of use. In group A: after placing and adjusting the graft in its place and replacing the posterior tympanomeatal flap to its position, the autologous PRP was inserted (as a plug) into external auditory canal (EAC) on the lateral surface of the graft and TM remnant (Fig. 1C). In group B: Gelfoam was inserted on the lateral surface of the graft and TM remnant in EAC. In both groups, only an outer EAC pack was left. Pressure dressing was left over the operated ear for 1 week. Patients were discharged in the same day of surgery. Broad spectrum systemic antibiotic was described for 1 week. The patients in this study were evaluated on the basis of postoperative graft taking, hearing improvement and complications. Successful closure of perforation was defined as an intact TM at 6 months postoperatively. Success in terms of hearing was defined as an improvement of 10 dB or greater at 6 months as used by Sergi et al. [10]. 2.2. Statistical analysis Statistical analyses were performed using SPSS 17 statistical software for Windows (SPSS Inc., Chicago, IL). The significance level was set at P < 0.05. Quantities data in patient and control groups
were compared using a t test. Categorical variables were compared with a chi-square test for sex and Fisher’s exact test was used for other outcome results. 3. Results Sixty-four patients who had large central dry TM perforation were included in this study, which constituted 8 males (25%) and 24 females (75%) in case group and 9 males (28.1%) and 23 females (71.9%) in control group with non-significant difference (P = 0.777). The mean age (SD) was 22.9 (9.16) for case group and 19.9 (14.11) for control group with also non-significant difference (P = 0.4588) (Table 1). The follow-up ranged from 6 to 16 months. At 6 months postoperatively, success rate (graft taking) in case group (100%) was significantly higher than in control group (81.25%) (P = 0.02). While no residual perforation was reported in case group, 6 cases (18.75%) showed residual perforation in control group. Success in terms of hearing gain (10 dB) revealed that in case group, success was achieved in 21 patients (65.6%) that is better than the success achieved in control group (11 patients, 34.4%) with non-quite statistically significant difference (P = 0.079). When comparing the success in terms of hearing gain (10 dB) in graft taken case only, the difference was found to be non-significant (P = 0.288) (Table 2). So the difference in hearing success related to closure of TM perforation. Preoperative mean (SD) of air bone gab (ABG) in group A was 23 (3.83) and in group B was 22.34 (8.33) with non-significant difference (P = 0.6852). While postoperative mean (SD) of ABG was 12.5 7.64 in group A and 14.91 7.23 without statistically significant difference (P = 0.1998). The mean (SD) hearing gain was 10.5 dB (6.97) and 7.43 dB (7.7) for group A and group B, respectively, with non-significant difference (Table 3). No graft was lateralized or displaced into the middle ear and no retraction pocket was observed during the follow-up period. There Table 1 Comparison between the studied groups regarding age and sex. Study groups
Case group
Control group
Variants
No.
%
No.
%
Patients Sex Male Female Age (years) Mean Range
32
100
32
100
8 24
25 75
9 23
NS, non-significant. * Chi-square test. ** Student’s t test.
22.8 9.2 12–45
28.1 71.9 20.9 11.1 12–48
P value
0.777* NS
0.4588** NS
M.W. El-Anwar et al. / Auris Nasus Larynx 42 (2015) 365–368 Table 2 Success rates according to graft take and hearing gain. Study groups
Case group
Variants
Number
Control group Percent (%)
Graft taking Success 32 100 0 0 Failure Hearing success in all cases 10 dB (success) 21 65.6 <10 dB (failure) 11 34.4 Hearing success in graft taken cases 10 dB (success) 21 65.6 <10 dB (failure) 11 34.4
P value
Number
Percent (%)
26 6
81.25 18.75
0.02* S
13 19
40.6 59.4
0.079* NS
13 13
50 50
0.288* NS
NS, non-significant; S, significant. * Fisher’s exact test.
Table 3 Air bone gab (ABG) and mean hearing gain results. Group A Preoperative ABG (mean SD) Postoperative ABG (mean SD) Mean hearing gain
Group B
P value
23 dB 3.83
22.34 dB 8.33
12.5 dB 7.64
14.91 dB 7.23
10.5 dB 6.97
7.43 dB 7.7
0.6852** NS (t = 0.4072) 0.1998** NS (t = 1.2961) 0.0995** NS (t = 1.6721)
NS, non-significant. ** Non-paired t test.
were no postoperaive complications such as SNHL, tympanosclerosis or thin atrophic areas. No infection was detected in case group but in control group there were four cases who had postoperative otorrhea caused by middle ear infection on top of residual perforation that were controlled by medical treatment, this infection rate in control group (12.5%) was significantly higher than in case group (P < 0.0001).
4. Discussion Myringoplasty is a reconstructive operation of the TM performed to prevent recurrent ear discharge and to improve hearing impairment caused by TM perforation [2,11]. PRP as a carrier of growth factors accelerates endothelial, epithelial, and epidermal regeneration, stimulates angiogenesis, enhances collagen synthesis and soft tissue healing, decreases dermal scarring, and promotes the hemostatic response to injury [12]. The autologous PRP is simple and easy to be prepared with no reported side effects [13]. Erkilet et al. [7] suggested that autologous PRP is effective in accelerating TM perforation healing in rats. This encourages us to try it in myringoplasty in large TM perforation in human, particularly as it is an autologous material. In current study, the graft take rate was perfect in all cases (100% success rate) with the use of PRP with significant higher take rate than without PRP use with no reported complication including infection that was reported to be significantly higher in control group. These results prove the role of autologous PRP in enhancing healing of TM even in large perforation. In addition, PRP as prepared in current study has a significant role against infection. This is not consistent with Bielecki et al. [14] and Tate and Crane [15] who reported that the presence of WBCs in high concentrations in PRP makes it act as bacteriocidal. No effect of PRP use on hearing gain in graft taked cases because hearing gain related to closure of TM.
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Our method is supposed to be safe with no fear of SNHL as PRP has no side effects and we use a simple method that does not use any additives such as anticoagulants or calcium. Also the use of autologous PRP had may advantages like it is safe (from patient’s blood no fear of infecious diseases), rapid (in 12 min) and easy to be prepared begin during induction of anesthesia and ready before step of its application so its preparation is not a burden on the length of surgery, low relative cost (syring and vacuum tube), no use of additives (no anticoagulant or any toxic materials) and it guards against infection. PRP was reported to aid in the initial stability of the grafted tissue at the recipient sites (as a result of its cohesive and adhesive nature). PRP may promote faster vascularization of the healing tissue by delivering growth factors that induce regeneration. Due to super saturation of the wound with PRP, growth factors fasten tissue regeneration [16]. It is easy to handle and apply PRP even easier than Gelfoam. The natural acceleration of patient healing achieved with PRP had been proven to be inherently safe. The PRP graft is derived from autologous blood drawn at the time of treatment. Any allergic potential would be due to additive agents (such as local anesthetics employed for patient comfort at the time of injection) [14,15] that were not needed in our study because the patient was under general anesthesia. The autologous nature of the sample also eliminates concern over disease transfer. It had also been shown that due to the presence of WBCs, PRP grafts are bactericidal [14,15]. The in vivo half-life time of platelets is about 7–10 days [17] that is a suitable duration for healing of the TM peroration with the enhancing effect of PRP. Beside the main role of autologous PRP GFs in healing, we depended on autologous PRP to provide protection to the operated site, hold the graft in situ and prevent sagging of the posterior canal wall instead of inner EAC pack avoiding pack complication as hypersensitivity reaction of variable degree, canal granulation, stenosis or discharge [18,19]. This is the first clinical study of topical application of autologous PRP during repair of large TM perforation caused by CSOM and proved to have a significant beneficial effect on healing. So topical autologous PRP application during myringolpasty is safe and highly efficient and successful. Autologous PRP not only enhances healing of chronic TM perforations but also avoids infection and obviates the need for inner EAC pack. Therefore, it is recommended to regularly use topical autologous PRP during myringoplasty and further studies are needed to be investigated its healing effect in patients who had well known healing compromise as with diabetes mellitus. Healing effect of autologous PRP, at the cellular level, on different layers of the TM is also need to be studied. 5. Conclusion Topical autologous PRP application during myringolpasty is safe and highly efficient and successful with no reported complication. Autologous PRP not only enhances healing of chronic TM perforations but also avoids infection and obviates need for inner EAC pack. Financial support The authors declare no financial support or interest to this study. Conflict of interest The authors declare no conflict of interest.
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