Copyright © 2017 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
REFERENCES1. Gulbrandsen SR, Jackson IT, Turlington EG. Recovery of a maxillary third molar from the infratemporal space via a hemicoronal approach. J Oral Maxillofac Surg 1987;45:279–282
2. Dawson K, MacMillan A, Wiesenfeld D. Removal of a maxillary third molar from the infratemporal fossa by a temporal approach and the aid of image-intensifying cineradiography. J Oral Maxillofac Surg
1993;51:1395–1397
3. Sverzut CE, Trivellato AE, Sverzut AT, et al. Removal of a maxillary third molar accidentally displaced into the infratemporal fossa via intraoral approach under local anesthesia: report of a case. J Oral Maxillofac Surg 2009;67:1316–1320
4. Selvi F, Cakarer S, Keskin C, et al. Delayed removal of a maxillary third molar accidentally displaced into the infratemporal fossa. J Craniofac Surg 2011;22:1391–1393
5. Dimitrakopoulos I, Papadaki M. Displacement of a maxillary third molar into the infratemporal fossa: case report. Quintessence Int 2007;38: 607–610
Effects of the Autologous
Platelet-Rich Plasma in Nasal
Pack on Postoperative Quality
of Life
Ihsan Kuzucu, MD, Guclu Kaan Beriat, PhD, Hande Ezerarslan, MD, Sedat Ozdemir, MD, and Sinan Kocaturk, PhD
Aim: The authors aimed to research the effects of autologous platelet-rich plasma, which is known for the positive effects on wound healing, on postoperatif living quality of the patients after using on nasal surgery.
Methods: Patients who undergo nasal operation according to randomized patient’s choice have been injected with saline merocel pack and platelet-rich plasma (PRP) in their nasal path. Postopera-tive is followed by 1 month; Nose Obstruction Symptom Evaluation (NOSE) scala score, bleeding, pain, and crust rate have been compared between 2 groups.
Results: As a result of the 1 month follow-up, it was seen that the treatment group experienced better results in terms of NOSE scale than the control group patients and this was significant difference in terms of NOSE. Less bleeding and crust was seen on the treatment group patients than the control group patients and statically sig-nificant difference was found. In terms of visual analogue scale score no statically significant difference was found between 2 groups.
Conclusion: According to the authors’ study on PRP, the authors found out that by using PRP wound can be healed faster in early period of postoperative. It was seen with the authors’ research that on postoperative early period crusts, bleeding and postoperative complaints are lesser.
Key Words:Nasal surgical procedures, pain measurement, platelet-rich plasma, quality of life, randomized controlled trial
I
n addition to their well-known function in haemostasis, platelets also release substances that promote tissue repair, angiogenesis, and inflammation.1 A damaged tissue recovers faster with the effect of the factors of growth in the platelet.2 Platelet-rich plasma (PRP) has been used in clinics for a long time to take advantage of this condition. Nowadays, PRP is being used for treatment in many areas. For example, it is being used in surgical operations (orthopedic operations, maxillofacial attempts, flap shifting operations, etc.), chronic wound recovery, ulcer, and burnt care.2Problems in the recovery of the wounds inside the nose (pain, crusts, bleeding, synechia) that might affect the life quality can be seen in some patients after nose operations.3 Although the positive effects of PRP in the sense of wound recovery have been indicated in many studies, during literature research we have found out that there are few studies with prospective control about the use of PRP in nasal surgery. With this study it is aimed to search the possible positive effects of the postoperative intranasal usage of PRP—the positive effects on tissue recovery of which is known—on the side effects indicated above in the patients who had nasal surgery and on the life quality of these patients.
METHODS
This single-blind, randomized, patient-controlled trial has been conducted at Ufuk University Dr RidvanEge Hospital between February and April 2014. Ankara University Ethics Committee approval was obtained prior to the start of the study (02-65-14\ 27.01.14). Consent information has been taken from each patient. Patients between 18 and 60 years who were scheduled to undergo bilateral nasal surgery were enrolled. Exclusion criteria were systemic disease, coagulation disorders, and patients who had nasal surgery before and who have a history of medi-cation. To which group would the patients who satisfy the criteria of suitability for the study and who accept to participate in the study has been determined by stratification and block randomiz-ation method. Random-number programme has been used for this process.
Fifty-three patients were included in the study. Patients were informed of the trial during the preoperative assessment visit. Written information regarding the trial was also provided at this time and consent has been taken from those wishing to take part. Twenty-seven patients were included in the PRP group, while 26 patients were included in the control group. Two patients from the PRP group and 1 patient from the control group have been excluded from the study for not showing up for the controls.
Operations were performed under general anesthesia by the same surgeon in Ufuk University Dr Ridvan Ege Hospital. Both the groups underwent the same surgical procedure. The surgeon who operated, did not know which group the patient was in. At the end of the surgery, merocel packs were placed in both groups’ bilateral nasal passages by the surgeon. An 8-cm-long Medtronic standard nasal dressing (Xomed Inc, Jacksonville, FL) merocel
From the Department of Otolaryngology Head and Neck Surgery, Ufuk University, Ankara, Turkey.
Received November 16, 2016.
Accepted for publication January 7, 2017.
Address correspondence and reprint requests to Dr Ihsan Kuzucu, MD, Department of Otolaryngology Head and Neck Surgery, Ankara Numune Training and Research Hospital, Ankara, 06100, Turkey; E-mail: ihsankuzucu@hotmail.com; ihsan.kuzucu@saglik.gov.tr The authors report no conflicts of interest.
Copyright#2017 by Mutaz B. Habal, MD
ISSN: 1049-2275
DOI: 10.1097/SCS.0000000000003664
The Journal of Craniofacial Surgery Volume 28, Number 3, May 2017 Brief Clinical Studies
Copyright © 2017 Mutaz B. Habal, MD. Unauthorized reproduction of this article is prohibited.
pack was used. The process of activating the merocel pack has been held by another researcher, the suitable application (saline/PRP) has been chosen according to which group the patient was in. After nasal surgery, in control group, the merocel pack was activated with normal saline. In working group patients, the merocel pack was activated with PRP.
Platelet-Rich Plasma Preparation
The PRP was prepared at the Ufuk University Dr Ridvan Ege Hospital Biochemistry Department. Prior to the start of the surgery, 20 mL of blood was drawn intravenously from patients and collected in sterile vacuum tube coated with anticoagulant citric acid and dextrose. Automated centrifugation machine was used for obtaining PRP with a speed of 1300 rpm for 10 minutes. After centrifugation, 3 layers were obtained: an upper straw colored fluid—platelet poor plasma; a middle buffy coat rich in platelet; a lower layer rich in red blood cell. The straw colored plasma was collected along with buffy coat and 1 mL of the red blood cell layer. This was centrifuged at 2000 rpm for 10 minutes. The PRP was obtained in the form of a red button at the bottom of the test tube. This was collected with the help of a pasteur pipette and transferred into a sterile tube. The platelet poor plasma was discarded. PRP obtained after the second centrifugation was placed in a sterile tube. For activation, 0.5 mL of calcium chloride was added to PRP.4
Same doses (2 mL) of PRP or saline (with a 20 Gneedle in sterilized 2.5 mL dental injector) injection has been given to the patients in both groups for the activation of merocel packs. Autologous platelet-rich plasma prepared with centrifugation into the merocel pack was administered up to 3 hours. Thus, the effectiveness of platelet-rich plasma was preserved. All the patients were given oral Augmentin (2 1 g) treatment for 7 days and all patients were given oral Parol (2 500 mg) for 2 days. Merocel pack was removed on the second-day morning. For the first postoperative month, autologous PRP and control groups were compared.
Outcome Measurements
Our primary outcome measurement was Nose Obstruction Symptom Evaluation (NOSE) scale. Preoperative values were compared with the first week and first month postoperatively. The NOSE scale scores were recorded at 3 different times; pre-operative score, postpre-operative first week, and postpre-operative first month. Total scores obtained from the NOSE scale were multiplied by 5, turned into percentages and statically evaluated.
Our secondary outcome measurements were pain levels while the packs were in the nose and pain associated with their removal. Patients were asked to record the severity of pain experienced on a graduated horizontal visual analogue scale (VAS), with a range of 0 to 10, 0 being no discomfort and 10 representing the worst pain imaginable. The scores were recorded at 2 different times; first in the morning after operation, and then in the morning of the second day after pack removal.
Our third outcome measurement was the control of bleeding while the packs were in situ and the amount of bleeding once they had been removed. We recorded evidence of bleeding using the following grading system: no bleeding¼ 0, bleeding for less than 3 minutes¼ 1, bleeding that settled with ice packs ¼ 2, bleeding that required repacking¼ 3. Complications such as difficulty in pack removal or pack fragmentation were also noted.
The nasal cavities were examined endoscopically at 4 weeks to assess the degree of crusting and synechia formation. Each of these findings was scored as follows: absent¼ 0, mild ¼ 1, or severe ¼ 2. Synechia formation was reported as present or absent.
Power Calculations
Power analysis identified 50 patients (25 per group) between groups with a power of 99% at 5% significance level.
Statistical Analysis
The statistical analysis of the data obtained has been made by using the ‘‘IBM Statistics SPSS21’’ programme. In the statistical evaluation of the parameters determined, the Kolmo-gorov – Smirnov test has been held to test whether the variables are normally distributed or not. As they have not been normally distributed, the Mann – Whitney U test has been used between groups, the Wilcoxon test has been used for the change in groups and for paired comparison. x2 analysis has been made for the categorical variables. P < 0.05 has been assumed as significant.
RESULTS
Participants
Fifty-three patients were enrolled for the trial. Data was col-lected on 50 patients. The remaining 3 patients were not available for follow-up. Twenty-five patients were randomized to have merocel packs with the injection of PRP. The remaining 25 patients had merocel packs with the injection of saline.
The average age of all patients was 33.70 1. 88 years with a range of 18 to 57 years. The average age of the PRP patients group was 33.20 10.61 years with a range of 18 to 57 years. The average age of the control (saline) patients group was 34.20 11.34 years with a range of 18 to 53 years. No significant difference was determined in terms of age distribution between groups (P: 0.749).
Among all patients who participated in the study 10 women (40%) and 15 men (60%) from the study group, 9 women (36%) and 16 men (64%) from the control group were included in the study. No significant difference was determined in terms of sex distribution between groups (P: 0.771).
Septoplasty surgery was performed for all patients who partici-pated in the study. Septoplasty and inferior turbinate radiofrequency operations were performed for 16 (64%) of the patients of the study group and 15 (60%) of the control group.
None of the patients were taking aspirin or anticoagulants.
Outcomes
First
Nose Obstruction Symptom Evaluation scale score in the study group was determined as preoperative 80 (65–95), postoperative first week 30 (10–50), postoperative first month 15 (5–25). Nose Obstruction Symptom Evaluation scale score in the control group was determined as preoperative 80 (45–90), postoperative first week 40 (20–65), postoperative first month 20 (10–30). Statisti-cally significant difference in terms of NOSE scale results between groups was determined (P < 0.001). Nose Obstruction Symptom Evaluation scale values are explained in Table 1.
TABLE 1. Nose Obstruction Symptom Evaluation Scale Score
Preoperative First Week First Month
PRP 80 (65–95) 30 (10–50) 15 (5–25) Control 80 (45–90) 40 (20–65) 20 (10–30)
P 0.092 0.009 0.001
Brief Clinical Studies The Journal of Craniofacial Surgery Volume 28, Number 3, May 2017
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Second
Visual analogue scale score average values in the study group were determined as: first day 4.52 0.653, second day (merocel pack removal) 5.56 0.92; VAS score average values in the control group were determined as: first day 4.64 0.757, second day (merocel pack removal) 5.68 0.90. When compared with the control group, less pain was observed in the PRP group. But no significant difference was found in pain scores between the 2 groups while the pack was in the nose. Individual responses during pack removal are shown in Table 2.
Third
After the removal of the merocel pack in the PRP group, bleeding less than 3 minutes was observed in 3 patients, and no bleeding was observed in 22 patients. In the control group, bleeding less than 3 minutes was observed in 9 patients, bleeding that has stopped after follow-up was observed in 2 patients, and no bleeding was observed in 14 patients. Significant difference between groups was determined in terms of bleeding P: 0.031). The values of bleeding after the removal of merocel pack are given in Table 3.
While the first month crusts score average was 0.24 0.43 in the PRP patient group, it was determined as 0.56 0.58 in the control group in the 4-week-clinical follow-up. Statistically significant difference was determined between groups in terms of crusts score (P: 0.038). Crusts scores are explained in Table 4.
At 4 weeks, none of the PRP patients had adhesions while 2 control group patients were noted to have adhesions.
Adverse Events
No adverse events occurred for either group during the study.
DISCUSSION
Platelet-rich plasma includes many healing factors such as trans-forming growth factor, platelet-derived growth factor, vascular endothelial growth factor, and epithelial growth factor. Addition-ally, PRP includes glycoprotein and fibrinogen that supports cell
migration.5Approximately 95% of the growth factors at the pre-synthesis state are released within 1 hour of PRP activation. These factors accelerate revascularization and healing of the wounded tissue.2
Problems such as crusts, bleeding, and pain are usually encoun-tered following nasal surgery. These problems have a negative impact on the quality of life. To avoid these problems, PRP that is known to accelerate wound healing has been applied via injection into the merocel pack following nasal surgery.
The number of studies investigating PRP in nasal surgery is limited. In a study investigating the healing properties of PRP, it has been applied to the nasal passage following endoscopic sinus surgery in 12 patients who have been followed up for 6 months. The results have revealed that PRP was beneficial in wound healing in nasal surgery and it could be used in endoscopic sinus surgery; however, the study population was severely limited.5 Rice6 has applied PRP to 1 nasal passage, and normal saline to the other in 13 volunteers and has reported no statistically significant differences. However, PRP could have effected the other nasal passage via systemic absorption and study population was also limited in this study. Salaheldin and Hussein7have applied PRP or normal saline to 60 patients divided into 2 equal groups. Patients were followed up for 2 months and the study showed statistically significant positive results in the PRP group.7
The NOSE scale has been proved to be an effective method in quantifying the postoperative success of nasal surgery.8,9 Our results have shown a significant difference between both preopera-tive and postoperapreopera-tive first week and month NOSE scores of 2 groups (P < 0.001). The NOSE score at the end of the first month in the study group was significantly lower than the control group (P¼ 0.001).
Both surgery itself and the nasal packs cause pain following the nasal surgery. Visual analogue scale score has been used to measure the pain in many studies.3,10In our study, average VAS scores were 5.68 for the control group and 5.56 for the study group and this difference was not statistically significant (P¼ 0.086)
Bleeding incidence following the removal of the merocel pack was found to be 0.12 in the PRP group and 0.50 in the control group. This difference between 2 groups was statistically significant (P¼ 0.031). Similarly, crust incidence in the first postoperative month was 0.24 in the PRP group and 0.56 in the control group. This was a significant difference (P¼ 0.038).
Nose Obstruction Symptom Evaluation scores were lower in the PRP group compared with the control group. PRP application resulted in less bleeding and crust formation. Lower NOSE scores were attributed to the lower crust and bleeding incidence in the PRP group.
Conclusively, both the groups performed well in our study. Based on the reports stating that PRP accelerates wound healing, patients recover more rapidly in the early postoperative period secondary to accelerated healing in the septal and conchalmucosa and have less complaints throughout this period.
ACKNOWLEDGMENTS
This study would not have been possible without the support and help of service nurses. The authors extend their thanks to all of them.
REFERENCES
1. Jurk K, Kehrel BE. Platelets: physiology and biochemistry. Semin Thromb Hemost 2005;31:381–392
2. Sommeling CE, Heynemann A, Hoeksema H, et al. The use of platelet rich plasma in plastic surgery: a systematic review. J Plast Reconstr Aesthet Surg 2013;66:301–311
TABLE 2. Average of Visual Analogue Scale Scores
First Day Pack Removal
PRP 4.52 0.653 5.56 0.92 Control 4.64 0.757 5.68 0.90
P 0.601 0.860
TABLE 3. Bleeding Scores
No Bleeding Less Than 3 Min Settled With Ice Required Packing P PRP 22 3 0 – 0.031 Control 14 9 2 –
TABLE 4. Average of Crusting
Crusting P
PRP 0.24 0.43 0.038
Control 0.56 0.58
The Journal of Craniofacial Surgery Volume 28, Number 3, May 2017 Brief Clinical Studies
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3. Wang J, Cai C, Wang S. Merocel versus nasopore for nasal packing: a meta-analysis of randomized controlled trials. PLoS One 2014;9:e93959
4. Pappalardo S, Guarnieri R. Efficacy of platelet-rich-plasma (PRP) and highly purified bovine xenograft (Laddec) combination in bone regeneration after cyst enucleation: radiological and histological evaluation. J Oral Maxillofac Res 2013;4:e3
5. Pomerantz J, Dutton JM. Platelet gel for endoscopic sinus surgery. Ann Otol Rhinol Laryngol 2005;114:699–704
6. Rice DH. Platelet-rich plasma in endoscopic sinus surgery. Ear Nose Throat J 2006;85:516–518
7. Salaheldin AH, Hussein A. Effect of platelet-rich plasma on nasal mucociliary clearance after submucous diathermy of inferior turbinate. Egyptian J Ear Nose Throat Allied Sci 2012;13:71–75 8. Kahveci OK, Miman MC, Yucel A, et al. The efficiency of Nose
Obstruction Symptom Evaluation (NOSE) scale on patients with nasal septal deviation. Auris Nasus Larynx 2012;39:275–279 9. Stewart MG, Witsell DL, Smith TL, et al. Development and validation
of the Nasal Obstruction Symptom Evaluation (NOSE) scale. Otolaryngol Head Neck Surg 2004;130:157–163
10. Prabhu V, Kaushik V, Rhodes S, et al. Foam nasal packs: a prospective, randomised, patient-controlled study. Rhinology 2007;45:242–247
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