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Wound healing in endoscopic sinus surgery: Phase 1 clinical trial evaluating the role of Chitogel with adjuvants.
Vediappan, Rajan Sundaresan; Bennett, Catherine; Cooksley, Clare; Bassiouni, Ahmed; Scott, John R; Al Suliman, Yazeed A; Lumyongsatien, Jate; Moratti, Stephen; Psaltis, Alkis J; Vreugde, Sarah; Wormald, Peter-John.
Afiliación
  • Vediappan RS; Department of Surgery - Otolaryngology Head and Neck Surgery, The University of Adelaide, Adelaide, South Australia, Australia.
  • Bennett C; Department of ENT, Unit-1, Head & Neck, Skull Base Surgery, Christian Medical College, Vellore, India.
  • Cooksley C; Department of Surgery - Otolaryngology Head and Neck Surgery, The University of Adelaide, Adelaide, South Australia, Australia.
  • Bassiouni A; Department of Surgery - Otolaryngology Head and Neck Surgery, The University of Adelaide, Adelaide, South Australia, Australia.
  • Scott JR; Department of Surgery - Otolaryngology Head and Neck Surgery, The University of Adelaide, Adelaide, South Australia, Australia.
  • Al Suliman YA; Department of Otolaryngology-Head & Neck Surgery, Dalhousie University, Halifax, Nova Scotia, Canada.
  • Lumyongsatien J; Department of Otolaryngology, Head and Neck Surgery, King Fahad Medical City, Riyadh, Saudi Arabia.
  • Moratti S; Department of Otorhinolaryngology Head and Neck Surgery, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand.
  • Psaltis AJ; Department of Chemistry, Otago University, Dunedin, New Zealand.
  • Vreugde S; Department of Surgery - Otolaryngology Head and Neck Surgery, The University of Adelaide, Adelaide, South Australia, Australia.
  • Wormald PJ; Department of Otolaryngology Head and Neck Surgery, Central Adelaide Health Network, Adelaide, Australia.
Clin Otolaryngol ; 48(2): 158-166, 2023 03.
Article en En | MEDLINE | ID: mdl-36317791
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.
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Senos Paranasales / Sinusitis / Rinitis / Procedimientos Quírurgicos Nasales Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Clin Otolaryngol Asunto de la revista: OTORRINOLARINGOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Reino Unido
Texto completo
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Texto completo: 1 Colección: 01-internacional Base de datos: MEDLINE Asunto principal: Senos Paranasales / Sinusitis / Rinitis / Procedimientos Quírurgicos Nasales Tipo de estudio: Clinical_trials Límite: Humans Idioma: En Revista: Clin Otolaryngol Asunto de la revista: OTORRINOLARINGOLOGIA Año: 2023 Tipo del documento: Article País de afiliación: Australia Pais de publicación: Reino Unido