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Leukocyte- and platelet-rich fibrin in endoscopic endonasal skull base reconstruction: study protocol for a multicenter prospective, parallel-group, single-blinded randomized controlled non-inferiority trial
Coucke, B., Van Hoylandt, A., Jorissen, M., Meulemans, J., Decramer, T., van Loon, J., Vander Poorten, V., Theys, T., Van Gerven, L.
Trials. 2023;24(1):488
Abstract
BACKGROUND Recent advances in endoscopic endonasal transsphenoidal approaches (EETA) for skull base lesions have resulted in a significant increase in extent and complexity of skull base defects, demanding more elaborate and novel reconstruction techniques to prevent cerebrospinal fluid (CSF) leakage and to improve healing. Currently, commercially available fibrin sealants are often used to reinforce the skull base reconstruction. However, problems have been reported regarding hypersensitivity reactions, efficacy, and costs. This trial aims to investigate autologous leukocyte- and platelet-rich fibrin (L-PRF) membranes as an alternative for commercially available fibrin glues in EETA-related skull base reconstruction reinforcement. METHODS/DESIGN This multicenter, prospective randomized controlled trial aims to demonstrate non-inferiority of L-PRF membranes compared to commercially available fibrin sealants in EETA cases (1) without intra-operative CSF-leak as dural or sellar floor closure reinforcement and (2) in EETA cases with intra-operative CSF-leak (or very large defects) in which a classic multilayer reconstruction has been made, as an additional sealing. The trial includes patients undergoing EETA in three different centers in Belgium. Patients are randomized in a 1:1 fashion comparing L-PRF with commercially available fibrin sealants. The primary endpoint is postoperative CSF leakage. Secondary endpoints are identification of risk factors for reconstruction failure, assessment of rhinological symptoms, and interference with postoperative imaging. Additionally, a cost-effectiveness analysis is performed. DISCUSSION With this trial, we will evaluate the safety and efficacy of L-PRF compared to commercially available fibrin sealants. TRIAL REGISTRATION ClinicalTrials.gov NCT03910374. Registered on 10 April 2019.
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Impact of titanium-prepared platelet-rich fibrin in type 1 fascia graft tympanoplasty on graft survival and hearing outcomes
Yavuz, R., Arslan, S., Imamoglu, M., Isik, A. U., Bahadir, O., Y. Cobanoglu HB, Yavuz, H. B.
Nigerian journal of clinical practice. 2023;26(7):921-927
Abstract
BACKGROUND Type 1 fascia graft tympanoplasty (T1FGT) is the mainstay surgical approach for the treatment of tympanic membrane perforations. The most widely used graft material is temporal muscle fascia, and graft take rates are reported differently. The methods to enhance graft take are still being investigated. Aim: The aim of our study was to investigate the effect of titanium-prepared platelet-rich fibrin (T-PRF) on graft take and hearing outcomes in T1FGT. MATERIALS AND METHODS Fifty-seven ears eligible for T1FGT were involved in the study and prospectively evaluated. T-PRF was applied with T1FGT in 27 ears. Thirty ears in the other group underwent only T1FGT. The patients underwent an otomicroscopic and audiometric examination in preoperative and postoperative 2(nd) week, 1(st) month, and 6(th) month. Both groups were evaluated in terms of hearing levels, infection, and graft take rates. RESULTS Two patients in the T1FGT + T-PRF group and seven patients in the T1FGT group had postoperative perforation (graft take rate: 92.6% versus 76.7%). The graft take rate was found to be increased in the T-PRF group although the difference was not statistically significant. In the T1FGT group, the percentage of infection was higher than in the T1FGT + T-PRF group. When the preoperative and postoperative 6(th)-month audiometry was compared, a statistically significant hearing gain was obtained for both groups. CONCLUSION In the treatment of tympanic membrane perforations, T-PRF applied over the fascia graft was shown to increase graft take rates and decrease the probability of infection. Further studies with larger samples are needed to demonstrate the effects of PRF.
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A Randomised Controlled Trial on the Efficacy of Topical Application of Autologous Platelet Rich Plasma (PRP) on Graft Uptake Rate in Adults Undergoing Type 1 Tympanoplasty for Inactive COM Mucosal Disease
Akash, Datta R, Suri GS, Mucha S, Sheikh MA, Taneja NS
Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India. 2023;75(Suppl 1):605-613
Abstract
To assess the efficacy of topical use of autologous platelet rich plasma (PRP) as a packing material in type 1 tympanoplasty in Mucosal Inactive COM disease by conducting a Randomized Controlled Trial in 80 patients. Prospective Randomized Controlled Trial. Total 80 patients were enrolled for the study after fulfilling the inclusion and exclusion criterion. Written and informed consent was taken from all patients. After taking detailed clinical history, the patients were divided in to two groups of 40 patients each by block randomization. Group A was the interventional group where topical autologous platelet rich plasma was applied on the graft during type1 tympanoplasty. In Group B, PRP not applied. Graft uptake rate was observed postoperatively after 1 month and 6 months. Successful graft uptake at 1st month was noted in 97.5% patients in Group A and 92.5% in Group B with a corresponding failure rate of 2.5% and 7.5% respectively. Successful graft uptake at 6th month was noted in 95% patients in Group A and 90% in Group B with a corresponding failure rate of 5% and 10% respectively. As observed from our study status of graft uptake and reperforations at 1st and 6th months subsequent to surgery and rate of post-operative infections were similar in both the groups irrespective of the status of receiving autologous platelet rich plasma. Trial registration Trial registered with CTRI (Clinical Trial Registry -India) (Reg. no CTRI/2019/02/017468 dated 05/02/2019). SUPPLEMENTARY INFORMATION The online version contains supplementary material available at 10.1007/s12070-023-03681-w.
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The impact of adding platelet-rich plasma during fat graft myringoplasty for managing medium-sized tympanic membrane perforations: A prospective randomized case-control study
Mandour MF, Elsheikh MN, Amer M, Elzayat S, Barbara M, Covelli E, Elfarargy HH, Tomoum M
American journal of otolaryngology. 2022;44(2):103755
Abstract
PURPOSE This study aimed to evaluate the effect of adding platelet-rich plasma (PRP) during FGM to close medium-sized TM perforations. METHODS This prospective randomized case-control study was conducted from February 2017 to March 2022. We included 320 patients with a medium-sized TM perforation with inactive mucosal otitis media. Transcanal FGM managed all patients under general or local anesthesia according to the patient preference. According to PRP, patients were divided into two groups: the first with PRP (170 patients) and the other without PRP (150 patients). We evaluated the closure rate of both groups one month, six months, and one year after the surgery. Also, we assessed the audiological performance before and one year after the operation for the patients with a successful closure. RESULTS The closure rate was 87.6 % in the first group and 72.7 % in the second group, with a statistically significant difference between both groups as the P-value, was 0.001. Successful closure of the ABG to <10 dB occurred in 95.3 % of group A and 90.8 % of group B without a statistically significant difference between both groups (P-value = 0.163). CONCLUSIONS This prospective comparative study on a relatively large number of patients revealed that FGM effectively closed medium-sized TM perforations. It also significantly improved postoperative audiological performance in both groups. Adding PRP during the FGM enhanced the closure success and the healing process without recorded complications. We recommend using the PRP in the routine FGM for closing medium-sized TM perforations.
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Outcome of Temporalis Fascia Myringoplasty With and Without use of Platelet Rich Plasma: A Randomized Control Trial
Sharma P, Parida PK, Preetam C, Mukherjee S, Nayak A, Pradhan P
Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India. 2022;74(Suppl 3):3832-3840
Abstract
To compare efficacy of temporalis fascia myringoplasty using platelet-rich plasma(PRP) {MP-PRP} and conventional emporalis fascia myringoplasty (MP-C) in treatment of moderate to large central tympanic-membrane(TM) perforation. Randomized-Control-Trial. We randomly assigned eighty-patients with COMmucosal-type with medium to large central TM-perforation and conductive hearing loss planned for primary myringoplasty to receive either MP-PRP orMP-C. Myringoplasty was performed through postauricular approach underlay graft using temporalis fascia. Primary-outcome was graft uptake (an intact TM) at 6 months postoperatively. Secondary-outcome was the postoperative hearing improvement measured by pure-tone-audiometry (PTA). Eighty-myringoplasties (MP-PRP group-40, MP-C group-40) done for 80 patients (male = 41; female = 39, age-group = 18-45-years) were included in analysis. At 6 months postoperatively graft uptake rate was 94.4% in MP-PRP and 92.1%% in MP-C group. There was no statistically significant difference in graft-uptake between the two groups (p = 0.358). Success in terms of hearing gain (≥ 10 dB) was achieved in 34 patients (89.5%) in MP-C and 37 patients (94.9%) in MP-PRP group. At 6 months follow-up; mean-PTA-average improved from 35.10 ± 5.401 dB to 27.74 ± 5.660 dB and mean ABG improved from 24.00 ± 5.204 dB to17.42 ± 5.559 dB in MP-C group. At 6 months followup; mean-PTA-average improved from 37.00 ± 6.144 dB to 26.65 dB and mean air bone gap (ABG) improved from 25.98 ± 5.736 dB to 16.21 ± 4.318 dB in MP-PRP group. No statistically significant differences in improvement in PTA-values were observed between both groups (p = 0.336).Postoperative complications were similar in both groups. Graft-uptake, hearing outcomes and complications of MP-PRP were similar to MP-C. MP-PRP offers no advantages over MP-C for treatment of TM perforation.
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A Comparative Study: Platelet-Rich Fibrin Packing as an Alternative to the Absorbable Gelatine in Tympanoplasty
Turhal G, Ozturk A, Kirazli T, Kaya I
The journal of international advanced otology. 2022
Abstract
BACKGROUND We aimed to investigate platelet-rich fibrin's potential role as packing material in both the middle ear and external auditory canal. METHODS Twenty-nine patients undergoing transcanal endoscopic type 1 cartilage tympanoplasty were included in this controlled prospective clinical study. Patients were randomly assigned to platelet-rich fibrin (n=14) or absorbable gelatine (n=15) groups. Preoperative and postoperative pure-tone audiometry results, graft healing rates, tympanometry values, and Glasgow Benefit Inventory scores were compared. RESULTS No significant postoperative complications were observed and the graft intake rate was 100% in both groups. Mean air-bone gap gain was 9.82 ± 4 dB HL in the postoperative first month and 10.08 ± 4.91 dB HL in the sixth postoperative month in the platelet-rich fibrin group. There was no statistically significant difference between the postoperative air-bone gap gains of the groups in the first (P=.537) and sixth month (P=.723) controls. There was no statistically significant difference in compliance (P = .453) between groups. The physical benefit scores of the Glasgow Benefit Inventory were significantly higher in the platelet-rich fibrin group (P=.01). There was no difference in general and social benefit scores (P > .05). CONCLUSION As a middle and external auditory canal packing agent, platelet-rich fibrin was as successful as absorbable gelatine in transcanal endoscopic cartilage tympanoplasty with similar functional results and graft healing rate.
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Autologous Fat Plus Platelet-Rich Plasma versus Autologous Fat Alone on Sulcus Vocalis
Tsou YA, Tien VH, Chen SH, Shih LC, Lin TC, Chiu CJ, Chang WD
Journal of clinical medicine. 2022;11(3)
Abstract
Sulcus vocalis is a frequent cause of glottic insufficiency that leads to incomplete vocal fold closure during phonation. Type II sulcus vocalis is defined as a partial defect of the lamina propria (LP). Treatment with fillers, such as fat or hyaluronic acid (HA), in the vocal folds is widely used, but the duration of effect is variable. Platelet-rich plasma (PRP) can enhance the survival of autologous fat in fat grafting, and also is used to treat sulcus vocalis. This study aimed to compare the effectiveness of autologous fat graft versus fat graft plus PRP to treat type II sulcus vocalis. Thirty-four patients with a voice handicap index (VHI) ≥ 11 were randomized to two groups, which received LP injections of fat graft (n = 17) or fat graft plus PRP (n = 17). At 1 month and 6 months after injection, the VHI decreased significantly in both groups. The fat plus PRP group had better Jitter, Shimmer, and noise to harmonic ratio (NHR) in 1 month and 6 months after surgery. The fat plus PRP group resulted in lower VHI scores one month after surgery, and stroboscopy revealed sustained smaller gaps after six months. These results indicate that a combination of fat graft plus PRP is safe and effective for treating sulcus vocalis type II and associated vocal atrophy.
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The Role of Platelet-Rich Plasma in Microlaryngeal Surgery; A Randomized Controlled Trial
Gaafar AH, Eldeghiedy AA, Elmaghraby RM, Nouh IS, Donia MM
The Journal of laryngology and otology. 2022;:1-26
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Efficacy of Platelet-Rich Plasma as an Adjuvant Therapy to Endoscopic Sinus Surgery in Anosmia Patients with Sinonasal Polyposis: A Randomized Controlled Clinical Trial
Goljanian Tabrizi A, Asadi M, Mohammadi M, Abedi Yekta A, Sohrabi M
Medical journal of the Islamic Republic of Iran. 2021;35:156
Abstract
Background: Treatment of patients with anosmia is a major therapeutic challenge. The present study evaluated the efficacy of platelet-rich plasma (PRP) in the treatment of anosmia in patients with sinonasal polyposis. Methods:In the present clinical trial, atotal of 48 patients with sinonasal polyposis with theIran Smell Identification Test (I-SIT) score of <6 who completed the medical treatment and were observed 3 months after the sinus surgery were included and randomly divided in to 2groups. After endoscopic sinus surgery, the intranasal injection of 1 mL PRP and normal saline was performed in the olfactory region in the intervention and control groups, respectively. Odor function was assessed using the I-SIT at the baseline and at the end of the studyby an independent samples ttest. Results: Based on the findings of the present study, the I-SIT improved in both groups during the follow-up, as it reached from 2.63 ± 2.63 to 5.85 ± 2.46 after oral steroid administration and 18.93 ± 1.14 after surgery in the intervention group and from the baseline of 2.10 ± 2.83 to 5.62 ± 2.99 after receiving standard medical treatment and 18.43 ± 1.36in the control groupafter surgery. Although this improvement was significant in both groups in either time interval (all with p<0.001), there was no significant difference between the 2groups in terms of changes in the I-SIT score (p=0.802). Conclusion: According to the current study, PRP injection showed no short-term effect on the recovery of olfactory function in patients with sinonasal polyposis.
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10.
Randomised clinical trial: Effect of administering platelet-rich fibrin to autologous fat tissue in injection laryngoplasty for vocal cord paralysis
Reksodiputro MH, Hutauruk SM, Koento T, Fardizza F, Hakim RYR, Audindra S, Yosia M
Annals of medicine and surgery (2012). 2021;68:102564
Abstract
The vocal cord in humans is essential in producing voice used in communication and interaction between us. Vocal cord paralysis causes dysphonia, which interferes with communication, causing disruptions towards social activity and daily activities. One of the managements for vocal cord paralysis is medialization and augmentation of the vocal cord through injection laryngoplasty. Autologous fat is one of the best fillers used in this procedure, but it is highly absorbable and can be reabsorbed very quickly when injected into body tissues. Platelet Rich Fibrin (PRF) is a biomaterial consisting of growth factors that are thought to improve fat tissue viability by increasing adipogenesis and angiogenesis. Improvement in fat viability will improve clinical outcomes after the laryngoplasty procedure, potentially reducing the number of repeated injections needed to achieve a satisfactory resolution to vocal cord paralysis. The study evaluates a combination of PRF and autologous microlobular fat compared with autologous microlobular fat alone on laryngoplasty. This single-blinded randomised control trial recruit a total of 18 patients, which are then randomised into the treatment and control groups. The evaluation was done via computerized acoustic analysis/Multidimensional Voice Program (MDVP) parameters and maximum phonation time. The MDVP results and maximum phonation time in both groups showed clinical improvement after the operation with no statistically significant differences.