Wound healing in endoscopic sinus surgery: Phase 1 clinical trial evaluating the role of Chitogel with adjuvants
Issued Date
2023-03-01
Resource Type
ISSN
17494478
eISSN
17494486
Scopus ID
2-s2.0-85142368441
Pubmed ID
36317791
Journal Title
Clinical Otolaryngology
Volume
48
Issue
2
Start Page
158
End Page
166
Rights Holder(s)
SCOPUS
Bibliographic Citation
Clinical Otolaryngology Vol.48 No.2 (2023) , 158-166
Suggested Citation
Vediappan R.S., Bennett C., Cooksley C., Bassiouni A., Scott J.R., Al Suliman Y.A., Lumyongsatien J., Moratti S., Psaltis A.J., Vreugde S., Wormald P.J. Wound healing in endoscopic sinus surgery: Phase 1 clinical trial evaluating the role of Chitogel with adjuvants. Clinical Otolaryngology Vol.48 No.2 (2023) , 158-166. 166. doi:10.1111/coa.13996 Retrieved from: https://repository.li.mahidol.ac.th/handle/20.500.14594/82389
Title
Wound healing in endoscopic sinus surgery: Phase 1 clinical trial evaluating the role of Chitogel with adjuvants
Other Contributor(s)
Abstract
Objectives: This study aimed to determine the safety and efficacy of Chitogel, with and without Deferiprone (Def) and Gallium Protoporphyrin (GaPP), as a promoter of wound healing to improve surgical outcomes after endoscopic sinus susgery. Design: A double-blinded, randomised control human clinical trial was conducted in patients undergoing ESS as a treatment for chronic rhinosinusitis. Participants underwent functional ESS or FESS with drill out as required and were randomised to receive test product Chitogel, Chitogel in combination with Def or Def-GaPP versus no packing (control). Setting: Ostial stenosis and persistent inflammation are the main reasons for revision endoscopic sinus surgery (ESS). Post-operative (PO) dressings can improve PO wound healing and patient outcomes after ESS. Participants: Eighty two patients were included in this study with 79 patients completing the study with 40 undergoing full house FESS and 39 FESS plus frontal drillout. Main Outcome Measures: Patients were followed up at 2, 6 and 12 weeks PO, and outcome scores such as SNOT-22, VAS and LKS, pre and post-surgery (12 weeks) were compared. Results: Seventy nine patients completed the study, there was a significant reduction in SNOT-22 score and improvement of VAS at 12 weeks in patients treated with Chitogel compared to control (p <.05). In those patients, the mean ostium area for the Chitogel and the Chitogel + Def + GaPP groups was higher across all three sinuses compared to the no-treatment control group, without statistical significance. Sphenoid sinus ostium was significantly more patent in patients treated with Chitogel compared to the control at the 12-week time point (p <.05). Conclusion: Chitogel as a PO dressing after ESS results in the best patient-reported symptom scores and objective measurements. The combination of Def and GaPP to Chitogel though proving safe, had no effect on the ostium patency or mucosal healing.