Autologous Fat Plus Platelet-Rich Plasma versus Autologous Fat Alone on Sulcus Vocalis
Journal of clinical medicine. 2022;11(3)
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.
Coblation Versus Bipolar Diathermy Hemostasis in Pediatric Tonsillectomy Patients: Systematic Review and Meta-Analysis
This study aimed to compare the outcomes of coblation versus bipolar diathermy in pediatric patients undergoing tonsillectomy. A systematic review and meta-analysis were performed per the Preferred Reporting Items for Systematic Reviews and Meta-analyses (PRISMA) Guidelines. An electronic search of information was conducted to identify all Randomized Controlled Trials (RCTs) comparing the outcomes of coblation versus bipolar in pediatric patients undergoing tonsillectomy. Primary outcome measures were intraoperative bleeding, reactionary hemorrhage, delayed hemorrhage, and post-operative pain. Secondary outcome measures included a return to a normal diet, effects on the tonsillar bed, operation time, and administration of analgesia. Fixed and random-effects models were used for the analysis. Seven studies enrolling 1328 patients were identified. There was a significant difference between coblation and bipolar groups in terms of delayed hemorrhage (Odds Ratio [OR] = 0.27, P = 0.005) and post-operative pain (standardized mean difference [MD] = -2.13, P = 0.0007). Intraoperative bleeding (MD = -43.26, P = 0.11) and reactionary hemorrhage did not show any significant difference. The coblation group improved analgesia administration, diet and tonsillar tissue recovery, and thermal damage for secondary outcomes. No significant difference was reported in terms of operation time. In conclusion, coblation is comparable to a bipolar technique for pediatric patients undergoing tonsillectomy. It improves postoperative pain and delayed hemorrhage and does not worsen intraoperative bleeding and reactionary hemorrhage.
Efficacy of Platelet-Rich Plasma as an Adjuvant Therapy to Endoscopic Sinus Surgery in Anosmia Patients with Sinonasal Polyposis: A Randomized Controlled Clinical Trial
Medical journal of the Islamic Republic of Iran. 2021;35:156
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.
Effectiveness and Adverse Effects of Tranexamic Acid in Bleeding during Adenotonsillectomy: A Randomized, Controlled, Double-blind Clinical Trial
International archives of otorhinolaryngology. 2021;25(4):e557-e562
Introduction Intra and postoperative bleeding are the most frequent and feared complications in adenotonsillectomy (AT). Tranexamic acid (TXA), which is known for its antifibrinolytic effects, has a proven benefit in reducing bleeding in hemorrhagic trauma and cardiac surgery; however, the effectiveness and timing of its application in AT have not yet been established. Objectives We aimed to evaluate the efficacy of TXA in controlling bleeding during and after AT and assess its possible adverse effects in children. Methods The present randomized, controlled, double-blind clinical trial included 63 children aged 2 to 12 years. They were randomly assigned to receive either intravenous TXA (10 mg/kg) or placebo 10 minutes before surgery. The volume of intraoperative bleeding, presence of postoperative bleeding, and adverse effects during and 8 hours after the surgery were assessed. Results No difference in bleeding volume was noted between the 2 groups (mean, 122.7 ml in the TXA group versus 115.5 ml in the placebo group, p = 0.36). No intraoperative or postoperative adverse effects were noted because of TXA use. Furthermore, no primary or secondary postoperative bleeding was observed in any of the participants. Conclusion In our pediatric sample, TXA (10 mg/kg) administration before AT was safely used, without any adverse effects. It did not reduce the bleeding volume in children during this type of surgery. Future studies should assess the use of higher doses of TXA and its administration at other time points before or during surgery.
Autologous Platelet- and Extracellular Vesicle-Rich Plasma Is an Effective Treatment Modality for Chronic Postoperative Temporal Bone Cavity Inflammation: Randomized Controlled Clinical Trial
Frontiers in bioengineering and biotechnology. 2021;9:677541
PURPOSE To determine the efficacy of autologous platelet- and extracellular vesicle-rich plasma (PVRP) to treat chronic postoperative temporal bone cavity inflammation (CPTBCI) after exhausting surgical and standard conservative therapies. MATERIALS AND METHODS Patients were randomly allocated to treatment with PVRP (PVRP group) or standard conservative methods (control group) in a setting of four once-monthly checkups and subsequent follow-up. The treatment outcome was measured with the Chronic Otitis Media Questionnaire-12 (COMQ-12), CPTBCI focus surface area, and CPTBCI symptom-free time after the fourth checkup. RESULTS Eleven patients from each group completed the trial; 95% of patients suffered from chronically discharging mastoid cavity (the type of CPTBCI). Within four checkups, the COMQ-12 score decreased statistically significantly in the PVRP group (p < 0.001) but not in the control group (p = 0.339). The CPTBCI foci surface area decreased statistically significantly between the first and second checkups (p < 0.0005) but not between other checkups (p > 0.05) in the PVRP group. No statistically significant differences in CPTBCI foci surface area were detected between checkups in the control group (p = 0.152). Nine patients from the PVRP group and three patients from the control group were CPTBCI symptom-free at the fourth checkup. The median symptom-free time was 9.2 months (95% CI [7.4, 11.9]) in the PVRP group. Cumulatively, 49% of patients in the PVRP group remained CPTBCI symptom-free for 12.7 months after the fourth checkup. CONCLUSION Autologous PVRP represents a novel additional and successful treatment modality for a chronically discharging radical mastoid cavity when the surgical and standard conservative treatment methods have been exhausted. TRIAL NUMBER https://clinicaltrials.gov (NCT04281901).
A Clinical Study of Platelet-Rich Fibrin Combined With Autologous High-Density Fat Transplantation in Augmentation Rhinoplasty
Ear, nose, & throat journal. 2021;:1455613211016902
OBJECTIVE This study was designed to analyze the clinical effect of autologous fat-granule transplantation in augmentation rhinoplasty and explore methods to improve the fat retention rate. METHODS A total of 70 enrolled patients were randomly divided into 2 groups: the platelet-rich fibrin (PRF) combined with high-density fat transplantation group (combined group) and the conventional fat-granule transplantation group (control group; n = 35 in each group). In the combined group, an appropriate amount of autologous fat was extracted and centrifuged, and the lower layer of high-density fat was taken and mixed with PRF isolated from whole blood for autotransplantation. In the control group, only fat was extracted and centrifuged for transplantation. The patients were followed up with for more than one year to observe the short- and long-term effects, complications, safety, and patient satisfaction. RESULTS Six months after the operation, the nasal shape was stable, the contour was higher and more stereoscopic than before, the average increase of nasal height was 3.0 mm in the combined group and 2.0 mm in the control group. No complications, such as fat embolism, infection, or necrosis occurred during the 1-year follow-up. The satisfaction rate between the 2 groups has statistical significance (P < .05). CONCLUSION Overall, PRF combined with autologous high-density fat transplantation is simple to perform, has a significantly increased fat-retention rate than the control group, and has stable long-term effects without obvious adverse reactions. A sufficient amount of fat and PRF transplantation can achieve a good orthopedic effect. Thus, this method can be widely used in clinical augmentation rhinoplasty.
To evaluate the role of Feracrylum (1%) as hemostatic agent in Tonsillectomy
Indian journal of otolaryngology and head and neck surgery : official publication of the Association of Otolaryngologists of India. 2021;73(2):240-245
Tonsillectomy is a common procedure performed globally. It is associated with morbidities like hemorrhage and pain. Various methods are employed to reduce them. The present study is aimed to evaluate the role of Feracrylum (1%) in traditional cold steel tonsillectomy and to measure the outcomes in terms of intra-operative bleed, intra-operative time and post operative pain and recovery. A prospective study was conducted in Department of ENT, ESI Medical College, Kalburgi Karnataka, India, for a period of two years between January 2019 to December 2020 In this study, a total of 60 patients were involved and divided them into two groups after fulfilling the inclusion and exclusion criteria. Thirty patients each undergoing tonsillectomy with the use of Feracrylum considered as Group I and without the use of Feracrylum in the tonsillar fossae considered as Group II. The study has been approved by Ethics committee and informed consent was obtained from all the study subjects. The amount of blood loss is calculated. Post operative pain based on VAS (Visual Analogue Scale) is assessed in both the groups. Assessment of recovery in days is estimated in both groups by reduced pain, gaining normal activity and normal food intake. In this study, intra-operative time in group I was 19.83 ± 3.93 min and in group II 27.16 ± 3.35 min (P < 0.001). The intra-operative blood loss in group I was 26.67 ± 4.81 ml and in group II 44.70 ± 7.59 ml (P < 0.001). Patients recovered from pain, resumed normal activity and food intake within 2-3 days in Group I and in contrast it took about 3-5 days on an average in group II. In this study, majority of the patients experienced mild pain in Group I when Feracrylum was used during hemostasis. In our study, the time taken by the patients to recover from pain, resume their normal activity and also with regard to normal food intake was rapid. On an average of 2-3 days was seen in Group I. Group II patients required 3-5 days to recover from pain and resuming normal activity and food intake. The P value of < 0.001 was highly significant. Our study has stressed that use of Feracrylum in cold steel tonsillectomy is relatively safe. Its use is associated with a significant decrease in surgical time and blood loss. Rapid recovery makes it favourable to be used in cold steel tonsillectomy.
Intravitreal bevacizumab (IVB) versus IVB in combination with pars plana vitrectomy for vitreous hemorrhage secondary to proliferative diabetic retinopathy: a randomized clinical trial
International journal of retina and vitreous. 2021;7(1):35
BACKGROUND The main purpose of this study is to compare the vitreous hemorrhage (VH) score reduction and visual acuity outcomes in patients with VH secondary to proliferative diabetic retinopathy (PDR) treated with intravitreal injections of bevacizumab (IVB) versus IVB and pars plana vitrectomy (IVB and PPV). METHODS Patients with VH secondary to PDR were randomized into 2 groups: in Group A, patients were treated with a total of 3 IVB (1.5 mg/0.06 ml) at 8-week intervals; and in Group B, patients received a single IVB (1.5 mg/0.06 ml) and, 7 days later, underwent PPV. Patients received an ophthalmic evaluation that included best-corrected visual acuity (BCVA), indirect ophthalmoscopy, and mode B echography at weeks 8, 16 and 24. VH was classified according to the Diabetic Retinopathy Vitrectomy Study classification as grade 1, 2 or 3. Change in VH score was the primary outcome measure and change in BCVA was the secondary outcome. RESULTS Seventy-three eyes of 66 patients were randomized and 70 eyes completed the 24-week follow-up visit. Mean VH score reduction (± SEM) of 0.4571 ± 0.0283 (p = 0.0014), 1.3429 ± 0.0393 (p < 0.0001) and 1.8286 ± 0.0438 (p < 0.001) was observed in Group A at 8, 16 and 24 weeks after treatment, respectively (Table 2; Fig. 2). In Group B, the reduction of VH score (± SEM) was 2.2571 ± 0.0720 (p = 0.0014), 2.2857 ± 0.0606 (p < 0.0001) and 2.2286 ± 0.0726 (p < 0.001) at 8, 16 and 24 weeks after treatment, respectively. Group comparison revealed a significantly greater reduction in mean VH score in Group B at 8 and 16 weeks after treatment (p < 0.0001). However, at 24 weeks this difference was no longer statistically significant (p = 0.1854). In Group A, mean (± SEM) BCVA showed an improvement of 0.00285 ± 0.0004 (p = 0.971), 0.5371 ± 0.0072 (p < 0.0001), 0.8143 ± 0.0001 (p < 0.0001) and 0.8543 ± 0.0008 (p < 0.0001) compared to baseline at 1, 8, 16 and 24 weeks after treatment, respectively. In Group B, mean (± SEM) BCVA showed an improvement of 0.3657 ± 0.0507 (p = 0.0002), 0.8857 ± 0.0385 (p < 0.0001), 0.9457 ± 0.0499 (p < 0.0001) and 0.9629 ± 0477 (p < 0.0001) compared to baseline at 1, 8, 16 and 24 weeks after treatment, respectively. No significant difference in BCVA improvement was observed between groups at 24 weeks after treatment. CONCLUSION PPV with preoperative IVB is associated with more rapid clearance of VH and improvement in BCVA than IVB injections alone. However, after 24 weeks of follow-up, the reduction in VH score and BCVA were similar between both treatment strategies. Trial Registration The project is registered in Plataforma Brasil with CAAE number 927354.7.0000.5440 and was approved by the Ethics Committee of the Clinics Hospital of Ribeirao Preto Medicine School of São Paulo University-Ribeirão Preto, São Paulo, Brazil (appreciation number 3.053.397 gave the approval).
Comparison of the effects of articaine, tetracaine, and lidocaine application on pain and hemorrhage during and after nasal pack removal
Revista da Associacao Medica Brasileira (1992). 2021;67(11):1696-1700
OBJECTIVE We purposed to compare the effects of certain local anesthetic applications on pain and hemorrhage caused by nasal pack removal. METHODS Design: Prospective, placebo-controlled study. Setting: Ataturk University Medical Faculty Hospital. This study was done in 90 patients who applied nasal packing after septoplasty. All patients were divided randomly into four groups. Each group was applied 2% lidocaine, 2% tetracaine, 4% articaine or 0.9% sodium chloride (NaCl) into their Merocel packs 15 min before removing. Verbal analog scale (VAS) score was registered from all patients, and the amount of hemorrhage was noted during the removal of the nasal packs and then for 30 min. RESULTS The study groups had significantly better pain scores than the control group during nasal pack removal and after 5 min (p<0.001). The articaine and the lidocaine groups had also better pain scores than the control group at 15th min after the removal of the nasal packs (p<0.05), but the tetracaine group had no better pain scores than the control group, which is statistically significant at p>0.05. Analysis of bleeding scores after the removal of packs showed that the articaine and the lidocaine groups had better bleeding scores than the control group (p<0.004 and p<0.033, respectively). CONCLUSION Topical articaine application into nasal packs just before removing in the patients who underwent septoplasty can be safely used for less pain, less hemorrhage, and more patient tolerance.
A randomized parallel design trial of the efficacy and safety of tranexamic acid, dexmedetomidine and nitroglycerin in controlling intraoperative bleeding and improving surgical field quality during septorhinoplasty under general anesthesia
Medical gas research. 2021;11(4):131-137
In this blinded clinical trial, we attempted to compare the efficacy and safety of administering tranexamic acid, dexmedetomidine and nitroglycerin in preventing intraoperative bleeding and improving the quality of the surgical field during septorhinoplasty under general anesthesia. A total of 105 patients scheduled for septorhinoplasty were enrolled and randomly assigned into three groups based on the balanced-block randomization method. First group received 1 μg/kg intravenous injection dexmedetomidine, second group received 10 mg/kg intravenous injection tranexamic acid and third group received 0.5 μg/kg nitroglycerin, intravenously. The study sample was composed of 105 participants with the total mean age of 25.85 ± 6.52 years, and 59.05% of participants were female and the mean of body mass index was 24.34 ± 2.57 kg/m(2). The results showed that there was no statistically significant difference in terms of arterial oxygen saturation, mean arterial pressure, heart rate, bleeding rate, duration of surgery, and surgeon satisfaction among the three groups; however, there was a significant difference in the extubation time, recovery time and the dose of administered propofol among the three groups. Dexmedetomidine reduced the dose of administered propofol while increasing the extubation time and recovery time. In the tranexamic acid group compared with the other two groups, the recovery time was shorter. However, all the three drugs could reduce intraoperative bleeding and lead to surgeon satisfaction. It can be concluded that all these three drugs can be utilized to control bleeding and improve the quality of the surgical field but the ultimate decision lies with the anesthesiologist's judgment and the conditions of the patient. The study protocol was registered in the Iranian Registry of Clinical Trials (registration No. IRCT20141209020258N121) on September 24, 2019 and it was ethically approved by the Ethical Committee of Arak University of Medical Sciences (approval No. IR.ARAKMU.REC.1397.355) on February 24, 2019.