Synchronous Micronized Inhalation Therapy Halves Healing Time After Fess: A Prospective Randomized Controlled Trial Comparing Simultaneous Vs Sequential Topical Administration

Authors

  • Lino Di Rienzo Businco Division of Otorhinolaryngology, Hospital S Giovanni Battista, Order of Malta, Rome, Italy Author
  • Andrea Di Rienzo Businco Division of Immuno-Allergology, S Pertini Hospital, Rome, Italy Author
  • Pasquale Longo Division of Otorhinolaryngology, Longevia Clinic, Rome, Italy Author
  • Irene Grossi Clinical Research Unit, Integria Foundation, Rome, Italy Author
  • Bruno Brandimarte Scientific Director, UBRI - Ultrastructural Biophysics Research Institute and Healthcare Technologies, Rome, Italy Author

DOI:

https://doi.org/10.47363/JOLRR/2026(5)153

Keywords:

FESS, Postoperative Care, Micronized Nasal Vaporization, Synchronous Administration, Simultaneous Therapy, Hyaluronic Acid, N-Acetylcysteine, Nasal Crusting, Mucosal Healing, Personalized Surgery

Abstract

Background: Postoperative management after functional endoscopic sinus surgery (FESS) determines surgical success. Early crusting, fibrin deposition, impaired mucociliary clearance and synechiae formation can compromise neo-ostial patency. While saline, hyaluronic acid and N-acetylcysteine are effective, the role of simultaneous vs sequential delivery is unknown.

Objective: To evaluate whether synchronous simultaneous administration of a multi-agent inhalation mixture via highly micronized ultrasonic vaporization improves mucosal healing and reduces crust formation compared to traditional sequential administration of identical active principles.

Methods: Prospective randomized controlled trial (n=80). Patients undergoing primary FESS for chronic rhinosinusitis with inferior/middle turbinate hypertrophy without polyposis were randomized 1:1 to Group A (sequential standard therapy: 20 mL saline irrigations + separate sprays/drops of N-acetylcysteine, hyaluronic acid, emollients, 3x/day) vs Group B (synchronous therapy: same principles combined into Mucus Regulation and Airway Detox mixtures, delivered simultaneously via 3 MHz ultrasonic vaporizer, 4-micron particles, positive pressure, 3x/week). Follow-up at 7,14,21,30 days. Primary endpoint: time to complete re-epithelialization (Lund-Kennedy score). Secondary: crusting at D7, synechiae, need for ambulatory debridement, VAS, SNOT-22, saccharin transit time, rhinomanometry.

Results: Complete healing: 15±3 days Group B vs 30±4 days Group A (p<0.001), 50% reduction. Marked crusting at D7: 15% vs 75% (p<0.05). Synechiae: 2.5% (1/40) vs 12.5% (5/40) (p<0.05). Need for debridement: 15% vs 60% (p<0.001). VAS respiratory patency at D14: 8/10 vs 5/10 (p<0.01). SNOT-22 and mucociliary transport significantly superior in Group B despite 95% fewer administrations.

Conclusion: Synchronous simultaneous delivery of mucolytic, hydrating, immunomodulatory and soothing agents via micronized vaporization is significantly more effective than sequential administration of same molecules. Delivery synchrony and modality are decisive factors in preventing crusts and accelerating physiological re-epithelialization after FESS.

Author Biographies

  • Lino Di Rienzo Businco, Division of Otorhinolaryngology, Hospital S Giovanni Battista, Order of Malta, Rome, Italy

    Division of Otorhinolaryngology, Hospital S Giovanni Battista, Order of Malta, Rome, Italy

  • Andrea Di Rienzo Businco, Division of Immuno-Allergology, S Pertini Hospital, Rome, Italy

    Division of Immuno-Allergology, S Pertini Hospital, Rome, Italy

  • Pasquale Longo, Division of Otorhinolaryngology, Longevia Clinic, Rome, Italy

    Division of Otorhinolaryngology, Longevia Clinic, Rome, Italy

  • Irene Grossi, Clinical Research Unit, Integria Foundation, Rome, Italy

    Clinical Research Unit, Integria Foundation, Rome, Italy

  • Bruno Brandimarte, Scientific Director, UBRI - Ultrastructural Biophysics Research Institute and Healthcare Technologies, Rome, Italy

    Scientific Director, UBRI - Ultrastructural Biophysics Research Institute and Healthcare Technologies, Rome, Italy

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Published

2026-10-15