None listed
Conditions
Brief summary
Chronic rhinosinusitis (CRS) is an inflammatory disease affecting around 5% of people in Western populations and is associated with significant morbidity. The aetiology of CRS remains unclear, although it is believed to involve a complex interaction between host immunity and a shift in the intranasal microbial community. Mucosal wound healing within this context is a complex and highly coordinated process, which is influenced by a number of host and environmental factors. A number of topical drugs and dressings have been investigated for their ability to enhance wound healing after sinus surgery, but so far none have been shown to be consistently better than no treatment at all. Retinoic acid is an active metabolite of vitamin A that has been widely used in dermatology for 50 years. Recently, several animal studies have suggested significant improvements in post surgical healing following treatment with a topical retinoid gel. This pilot study aims to observe the effect of isotretinoin to: 1) understand the potential for use in mucosal wound healing in the context of chronic sinusitis, 2) Improve outcomes following surgery, 3) Assist development of targeted approaches to improving perioperative care Study endpoints will be clinical scores combined with laboratory measurements of healing (histology), and microbiology.
Interventions
Pilot RCT. 32 newly diagnosed patients with chronic sinusitis (CRS) will be recruited over 18 months. These patients will be on the waiting list for endoscopic sinus surgery, but have not yet undergone surgery.
Following informed consent to participate in the study, 2 weeks prior to surgery, a patient questionnaire to obtain subjective patient symptom scores (SNOT-22) will be performed. Swabs will be taken from the middle meatus to provide baseline data. This is a non-invasive procedure perform
Pilot RCT. 32 newly diagnosed patients with chronic sinusitis (CRS) will be recruited over 18 months. These patients will be on the waiting list for endoscopic sinus surgery, but have not yet undergone surgery. Following informed consent to participate in the study, 2 weeks prior to surgery, a patient questionnaire to obtain subjective patient symptom scores (SNOT-22) will be performed. Swabs will be taken from the middle meatus to provide baseline data. This is a non-invasive procedure performed under endoscopic guidance, which is routinely undertaken in ORL clinics to guide appropriate antibiotic therapy for patients with sinusitis. Patients will then have topical anesthesia applied to the nasal cavity (co-phenylcaine or equivalent). A small, 3-5mm region of the antero-inferior aspect of the middle turbinate will be biopsied to create a wound. Patients will then be allocated numbered but unmarked drug packs (double blinded) in a computer generated random sequence, to receive 2 weeks of either: 1) isotretinoin capsule 10mg once daily 2) a placebo capsule Monitoring of medication adherence will be assessed by drug packet return. Two weeks later, at the time of surgery, the SNOT-22 will be again performed by the patient as well as an intraoperative endoscopic healing score (Lund-Kennedy) by the surgeon. Swabs will again be taken from the middle meatus. The inferior aspect of the middle turbinate, which is often resected routinely, will be biopsied to remove both the lesion made in clinic and a small amount of the surrounding, uninjured mucosa. Following surgery, patients will be continued on study medications (including placebo) at the same dose and frequency as the previously two weeks plus, for another two weeks. Patients will also be given any additional routine medications (usually antibiotics and steroids) as per clinical needs. Patients will be seen again at 2 weeks following surgery, at which point swabs will again be taken, along with the SNOT-5 and Lund-Kennedy scores. After this, patients will be discharged from the study and study medications (isotretinoin or placebo) stopped.
Sponsors
Associate Professor Richard Douglas
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
16 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients newly diagnosed with CRS, are eligible for sinus surgery and on the waiting list for endoscopic sinus surgery, but not yet undergone surgery. Patients providing fully informed consent to participate in this study.
Exclusion criteria
Patients who are acutely unwell. Patients with cystic fibrosis. Patients with a history of previous nasal surgery. Male patients less than 16 years of age Female patients less than 45 years of age (owing to isotretinoin teratogenicity risk) Immunodeficiency (congenital or acquired) Congenital mucociliary problems (e.g. primary ciliary dyskinesia) Non-invasive and invasive fungal sinus disease Systemic vasculitis and granulomatous diseases History of cocaine abuse; Patients requiring sinus surgery for neoplasia Patients unable to consent (e.g. lack of mental capacity)
Outcome results
None listed