Randomized Clinical Trial to Evaluate the Efficacy and Tolerability of Nebulized Hyaluronic Acid and Xylitol Based Solution after Septoturbinoplasty
<p>Mean (95% confidence interval) Modified Lund-Kennedy endoscopic scale (MLK) Oedema Scale along time according to the intervention group. D0: Day 0; D7: Day 7; D14: Day 14; D28: Day 28.</p> "> Figure 2
<p>Mean (95% confidence interval) Modified Lund-Kennedy endoscopic scale (MLK) Discharge Scale along time according to the intervention group. D0: Day 0; D7: Day 7; D14: Day 14; D28: Day 28.</p> "> Figure 3
<p>Mean (95% confidence interval) Sino-Nasal-Outcome-Test 22 (SNOT-22) Score along time according to the intervention group. D0: Day 0; D7: Day 7; D14: Day 14; D28: Day 28.</p> "> Figure 4
<p>Mean (95% confidence interval) Nose Obstruction Symptom Evaluation (NOSE) Scale along time according to the intervention group. D0: Day 0; D7: Day 7; D14: Day 14; D28: Day 28.</p> "> Figure 5
<p>Mean (95% confidence interval) Visual Analogue Scale (VAS) Score along time according to the intervention group. D0: Day 0; D7: Day 7; D14: Day 14; D28: Day 28.</p> ">
Abstract
:1. Introduction
2. Materials and Methods
2.1. Study Design and Setting
2.2. Ethical Considerations
2.3. Inclusion Criteria
2.4. Randomization and Allocation Concealment
2.5. Study Interventions
2.6. Data Collection
- Sinonasal medical assessment for diagnosis through recorded endoscopy and radiological evaluation (confirmation or disproval of a septal deviation, its severity, and the potential necessity for septoplasty with cauterization).
- Sino-Nasal-Outcome-Test survey of 22 indicators (SNOT-22), Visual Analogue Scale for nasal burning sensations, smell disturbances, taste disturbances, nasal bleeding, purulent rhinorrhea, headache, and sore throat (VAS main), and Nasal Obstructive Symptom Evaluation Scale (NOSE).
- Medical assessment by a detailed anamnesis (including potential concomitant treatments, if applicable).
- Review of their medical history
- Demographic data.
2.7. Primary Outcome
2.8. Secondary Outcome
- Evaluation of the tolerability of the product
- Assessment of the clinical evolution post-surgery
- Evaluation of patients’ satisfaction with the treatment regarding their crust and adhesions.
3. Results
- standard saline arm (group 1): 29 patients.
- standard saline plus HA and Xylitol arm (group 2): 29 patients.
3.1. Objective Parameters Assessment
3.2. Subjective Parameters Assessment
4. Discussion
5. Conclusions
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Acknowledgments
Conflicts of Interest
References
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Aluneb Isotónico® Group | Control Group | p-Value | |
---|---|---|---|
N | 27 | 22 | |
Age, years | 40.30 (17.10) | 43.45 (13.53) | 0.47 |
Sex, % women | 12, 44% | 5, 23% | |
Weight, kg | 67.74 (16.81) | 77.91 (13.17) | 0.02 |
Height, cm | 171.33 (9.66) | 173.81 6.58) | 0.30 |
Mean VAS score | 17.74 (7.41) | 14.50 (9.48) | 0.20 |
Mean NOSE scale | 11.07 (4.64) | 9.36 (5.10) | 0.23 |
Mean SNOT-22 test | 29.07 (11.48) | 25.05 (14.05) | 0.29 |
Crust All Patients | ||||||
---|---|---|---|---|---|---|
D0 | Frequencies | Grade | Total | Risk ratio | ||
2 or + | 0–1 | |||||
Treatment | Aluneb Isotónico® | 2 | 24 | 26 | 1.62 (0.16, 16.61) | |
Control group | 1 | 20 | 21 | |||
Total | 3 | 44 | 47 | |||
D7 | Frequencies | Grade | Total | Risk ratio | ||
2 or + | 0–1 | |||||
Treatment | Aluneb Isotónico® | 8 | 17 | 25 | 0.45 (0.24, 0.84) | |
Control group | 15 | 6 | 21 | |||
Total | 23 | 23 | 46 | |||
D14 | Frequencies | Grade | Total | Risk ratio | ||
2 or + | 0–1 | |||||
Treatment | Aluneb Isotónico® | 8 | 16 | 24 | 0.51 (0.27, 0.98) | |
Control group | 13 | 7 | 20 | |||
Total | 21 | 28 | 44 | |||
D28 | Frequencies | Grade | Total | Risk ratio | ||
2 or + | 0–1 | |||||
Treatment | Aluneb Isotónico® | 2 | 16 | 18 | 0.24 (0.06, 1.01) | |
Control group | 6 | 7 | 13 | |||
Total | 8 | 23 | 31 |
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Baptista, P.; Moffa, A.; Giorgi, L.; Casale, M. Randomized Clinical Trial to Evaluate the Efficacy and Tolerability of Nebulized Hyaluronic Acid and Xylitol Based Solution after Septoturbinoplasty. J. Pers. Med. 2023, 13, 1160. https://doi.org/10.3390/jpm13071160
Baptista P, Moffa A, Giorgi L, Casale M. Randomized Clinical Trial to Evaluate the Efficacy and Tolerability of Nebulized Hyaluronic Acid and Xylitol Based Solution after Septoturbinoplasty. Journal of Personalized Medicine. 2023; 13(7):1160. https://doi.org/10.3390/jpm13071160
Chicago/Turabian StyleBaptista, Peter, Antonio Moffa, Lucrezia Giorgi, and Manuele Casale. 2023. "Randomized Clinical Trial to Evaluate the Efficacy and Tolerability of Nebulized Hyaluronic Acid and Xylitol Based Solution after Septoturbinoplasty" Journal of Personalized Medicine 13, no. 7: 1160. https://doi.org/10.3390/jpm13071160
APA StyleBaptista, P., Moffa, A., Giorgi, L., & Casale, M. (2023). Randomized Clinical Trial to Evaluate the Efficacy and Tolerability of Nebulized Hyaluronic Acid and Xylitol Based Solution after Septoturbinoplasty. Journal of Personalized Medicine, 13(7), 1160. https://doi.org/10.3390/jpm13071160