Wound healing in endoscopic sinus surgery: Phase 1 clinical trial evaluating the role of Chitogel with adjuvants.
Chitogel™
absorbable packing
biomaterials
chronic rhinosinusitis
drug-eluting stents
endoscopic sinus surgery
haemostasis
nasal packing
removable packing
rhinology
wound healing
Journal
Clinical otolaryngology : official journal of ENT-UK ; official journal of Netherlands Society for Oto-Rhino-Laryngology & Cervico-Facial Surgery
ISSN: 1749-4486
Titre abrégé: Clin Otolaryngol
Pays: England
ID NLM: 101247023
Informations de publication
Date de publication:
03 2023
03 2023
Historique:
revised:
07
10
2022
received:
02
07
2022
accepted:
16
10
2022
pubmed:
2
11
2022
medline:
22
2
2023
entrez:
1
11
2022
Statut:
ppublish
Résumé
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. 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). 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. 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. 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. 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). 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.
Types de publication
Randomized Controlled Trial
Clinical Trial, Phase I
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
158-166Subventions
Organisme : Hospital Research Foundation
ID : Australian Government Research Training Program Scheme
Organisme : University of Adelaide
ID : The Queen Elizabeth Hospital & Basil Hetzel Instit
Informations de copyright
© 2022 The Authors. Clinical Otolaryngology published by John Wiley & Sons Ltd.
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