None listed
Conditions
Brief summary
Chronic rhinosinusitis (CRS) affects between 12 and 15.2% of the adult population in the United States, with direct and indirect costs of management exceeding twelve billion US dollars annually. In patients whose CRS is refractory to pharmacological or medical management, functional endoscopic sinus surgery (FESS) has become a well-recognised, established and safe surgical option to re-open sinus ostia, restoring the physiological drainage pathways of the sinuses and facilitating mucociliary clearance. This enables the thorough application of topical therapies to the sinonasal mucosa, increasing the likelihood of successful medical management. The efficacy and desirable outcomes of FESS can be reduced by postoperative inflammation, polyp recurrence and adhesions. Topical steroids in the form of nasal sprays are well established in preventing these adverse outcomes and as such, there has been considerable recent investigation of intraoperative placement of bioabsorbable products to both improve and increase the longevity of the desired postoperative outcomes, thereby reducing rates of revision FESS. To our knowledge, whether steroid-impregnated bioabsorbable synthetic polyurethane foam (Nasopore®) confers any objective or subjective postoperative benefit over steroid-impregnated self-crosslinked hyaluronic acid (PureRegen®), and the systemic and ocular safety of their use have not yet been studied.
Interventions
This study will compare the outcomes of the placement of the below devices following functional endoscopic sinus surgery (FESS).
- Steroid-impregnated Nasopore® (bioabsorbable polyurethane foam)
- Steroid impregnated PureRegen® (self-crosslinked hyaluronic acid sinus dressing)
The placement of the device will be placed to medialise the middle turbinate in both nasal cavities at the conclusion of the surgical procedure by the surgeon, but whilst patients are still under general anaesthesia. Thes
This study will compare the outcomes of the placement of the below devices following functional endoscopic sinus surgery (FESS). - Steroid-impregnated Nasopore® (bioabsorbable polyurethane foam) - Steroid impregnated PureRegen® (self-crosslinked hyaluronic acid sinus dressing) The placement of the device will be placed to medialise the middle turbinate in both nasal cavities at the conclusion of the surgical procedure by the surgeon, but whilst patients are still under general anaesthesia. These will be left in place for 14 days, after which they will either be fully absorbed or the remnants suctioned out in outpatient clinic. Steroid used will be 1mg of budesonide on either side.
Sponsors
Gosford Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1) CT Lund-Mackay score was greater and equal to 1, AND 2) Minimum trial of at least eight weeks’ duration of a topical intranasal corticosteroid, AND 3) Short course of systemic corticosteroid (CRSwNP) OR either a short-course of a broad spectrum / culture-directed systemic antibiotic OR the use of a prolonged course of systemic low-dose anti-inflammatory antibiotic (CRSsNP) 4) Post-medical treatment total SNOT-22 score greater than or equal to 20.
Exclusion criteria
- Immunodeficiency - Cystic fibrosis - Rhinologic granulomatous disease - Use of oral/nasal steroids from 30 days preoperatively to 30 days postoperatively - Previous sinus surgery - Aspirin intolerance - Asthma - Mucociliary disorder - History of Glaucoma - Unable to provide informed consent - Unable to commit to attending follow-up appointments
Outcome results
None listed