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1.
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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2.
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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3.
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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4.
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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5.
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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6.
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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7.
Effect of Platelet-Rich Plasma on Corneal Epithelial Healing after Phototherapeutic Keratectomy: An Intraindividual Contralateral Randomized Study
Kamiya K, Takahashi M, Shoji N
BioMed research international. 2021;2021:5752248
Abstract
PURPOSE To assess the effect of platelet-rich plasma (PRP) on the healing response of the corneal epithelium in eyes undergoing phototherapeutic keratectomy (PTK). METHODS We prospectively examined 20 eyes of 10 patients undergoing bilateral PTK for granular corneal dystrophy or band keratopathy. Patients were randomly assigned to start topical administration of PRP ophthalmic suspension (PRP group) or artificial tears (control group) 4 times daily for 2 weeks. Immediately, 1, and 2 days, and 1 week after PTK, we quantitatively measured the staining area of the corneal epithelium, using slit-lamp photography. We also determined the subjective symptoms and the satisfaction, using the visual analogue system (VAS). RESULTS The staining area in the PRP group was significantly smaller than that in the control group on days 1 and 2 (Wilcoxon signed-rank test, p = 0.022 and p = 0.017, respectively), but not on day 7 (p = 0.317). The recovery rate of the corneal epithelium in the PRP group was significantly higher than that in the control group on days 1 and 2 (p = 0.022 and p = 0.017, respectively), but not on day 7 (p = 0.317). We found no significant differences in pain (p = 0.139), foreign body sensation (p = 0.108), epiphora (p = 1.000), or satisfaction (p = 0.295), between the two groups. Postoperative complications did not occur in any of the eyes in the study. CONCLUSIONS The PRP treatment was effective for enhancing corneal epithelial recovery in the early postoperative period, without significant adverse events, in post-PTK-treated eyes, suggesting that it may hold promise as one of the treatment options for treating such postsurgical patients.
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8.
Efficacy of topical application of autologous platelet-rich plasma in adult tonsillectomy patients: a randomised control study
Nanditha S, Gopalakrishnan S, Karthikeyan P, Singh Bakshi S
The Journal of laryngology and otology. 2021;:1-6
Abstract
OBJECTIVE Tonsillectomy is a painful surgery performed in cases of recurrent tonsillitis. Application of platelet-rich plasma to diminish the pain and morbidity post-tonsillectomy is gaining importance. This study evaluated post-operative pain and morbidity after autologous platelet-rich plasma application on the tonsil beds during tonsillectomy. METHOD Participants were randomised into group 1 (n = 28, peri-operative platelet-rich plasma intervention) and group 2 (n = 28, control). Post-tonsillectomy, patients were assessed (day 0, 1, 2, 3, 7 and 14) for pain, healing and time taken to return to normal activity. Data were analysed by independent t-test and chi-square test with p ≤ 0.05 as the significance level. RESULTS A significant decrease in the mean pain score up to day 7 (p < 0.05) and tonsillar fossae healing on days 2 and 3 (p < 0.05) post-tonsillectomy was noted. The majority of the patients returned to their routine activities after a week post-tonsillectomy. CONCLUSION Platelet-rich plasma application was effective in accentuating healing and reducing post-tonsillectomy pain and morbidity.
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9.
Therapeutic Efficacy of Autologous Platelet Concentrate Injection on Macular Holes with High Myopia, Large Macular Holes, or Recurrent Macular Holes: A Multicenter Randomized Controlled Trial
Kim M, Won JY, Choi SY, Kim M, Ra H, Jee D, Kwon JW, Kang KD, Roh YJ, Park YG, et al
Journal of clinical medicine. 2021;10(12)
Abstract
We aimed to evaluate the anatomical and functional outcomes of pars-plana vitrectomy (PPV) with or without autologous platelet concentrate (APC) injection in patients with recurrent macular holes (MHs), large MHs, or MHs with high myopia. This multicenter, prospective, interventional randomized controlled trial was conducted from March 2017 to April 2020. Participants were randomly allocated to a PPV group or a PPV+APC group. All participants underwent standard 25-gauge PPV, and eyes in the PPV+APC group underwent PPV with intravitreal APC injection before air-gas exchange. A total of 117 patients were enrolled (PPV group: n = 59, PPV+APC group: n = 58). Hole closure was achieved in 47 participants (79.7%) in the PPV group and 52 participants (89.7%) in the PPV+APC group. There were no between-group differences in the anatomical closure rate or functional outcomes including best-corrected visual acuity, metamorphopsia, pattern-reversal visual evoked potential, or Visual Function Questionnaire-25 score. The use of APC injection does not improve the anatomical and functional outcomes of surgery for large MHs, recurrent MHs, or MHs with high myopia. The adjunctive use of APC can be considered in selected cases because it is not inferior to conventional MH surgery, is relatively simple to perform, and is not affected by the surgeon's skill.
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10.
The effect of platelet-rich fibrin (PRF) on wound healing, adhesion, and hemostasis after endoscopic sinus surgery in patients with nasal polyposis
Sari H, Karaketir S, Kumral TL, Akgun MF, Gurpinar B, Hanci D, Berkiten G, Uyar Y
American journal of otolaryngology. 2021;42(5):103010
Abstract
PURPOSE Chronic rhinosinusitis (CRS) is one of the most common chronic diseases seen worldwide. Endoscopic sinus surgery (ESS) has become a widely accepted procedure for medically refractory chronic rhinosinusitis and nasal polyps. Prevention of revision surgery often depends on good wound healing and less adhesion formation. In recent years, the effects of platelet-rich fibrin (PRF) on tissue healing have been addressed in many surgical branches, especially for dental implant surgery and plastic surgery. METHODS This prospective study was conducted with 50 patients who underwent endoscopic sinus surgery for the diagnosis of nasal polyposis. While the middle meatus in one nasal cavity was filled with PRF and supported with Nasopore, only Nasopore was used in the other nasal cavity middle meatus. The patients were followed up clinically at weeks 1, 2, 3, 4, 8, and 12 postoperatively. The assessor determined the presence of adhesion, crusting, bleeding, frontal ostium stenosis, granulation, and infection, and if present, the grades of these complications were scored according to a questionnaire. RESULTS In our study, adhesion, infection, bleeding, granulation, and frontal ostium stenosis were less common in the PRF group, and a statistically significant difference was found between the groups. CONCLUSION In our study, better results were obtained in terms of adhesion, infection, bleeding, granulation, and frontal ostium stenosis after ESS as a result of the effects of PRF on wound healing. The application of PRF is an inexpensive and easy procedure. PRF can be a good alternative to other types of tampons after ESS.
