None listed
Conditions
Brief summary
This research is aimed at improving outcomes for patients with chronic rhinosinusitis post endoscopic sinus surgery. A dissolvable dressing Chitodex (CD) gel has already been known to be beneficial to postoperative bleeding and healing after endoscopic sinus surgery. We aim to further improve its effects by combining the current formulation with budesonide (a steroid solution) and mupirocin (an antibacterial agent). We have specifically targeted patients in the immediate post endoscopic sinus surgery setting because in previous studies, we have found that biofilm-positive patients compared to biofilm-negative patients have worse outcome post surgery in both symptoms and nasoendoscopy scores, requiring repeated courses of antibiotic treatment and extra postoperative visits (Singhal et al 2008). Therefore in this study we hope to investigate if the eradication of biofilms combined with the improved wound healing properties of using Chitodex gel incorporated with mupirocin and budesonide (CBM gel) could prevent patients from progressing to the subset of recalcitrant disease. The specific aims of this study is to 1. To investigate the effects of Chitodex + Budesonide + Mupirocin (CBM) gel in post sinonasal surgery patients with chronic rhinosinusitis (CRS) 2. Compare the change in nasal microbiome post endoscopic sinus surgery The primary end point is measured by: 1) Eradication of bacteria confirmed with microbiological swab 2) Independently scored video endoscopic examination of sinuses pre and post treatment 3) Patient's symptoms score pre and post treatment The secondary end point is to: 1. Compare the change in nasal microbiome post endoscopic sinus surgery
Interventions
Patients who meet ALL of the inclusion/exclusion criteria will be offered participation in this study and will be randomised into treatment and control group after informed consent has been obtained.
After patient has given consent, they will be randomised into one of three groups:
1. Test group 1: To receive Chitodex (10ml of succinyl chitosan + 300mg of dextran aldehyde) + Budesonide (Pulmicort) 2mg/4mL + Mupirocin 20mg OR
* Budesonide and Mupirocin is incorporated into the gel complex
2. Te
Patients who meet ALL of the inclusion/exclusion criteria will be offered participation in this study and will be randomised into treatment and control group after informed consent has been obtained. After patient has given consent, they will be randomised into one of three groups: 1. Test group 1: To receive Chitodex (10ml of succinyl chitosan + 300mg of dextran aldehyde) + Budesonide (Pulmicort) 2mg/4mL + Mupirocin 20mg OR * Budesonide and Mupirocin is incorporated into the gel complex 2. Test group 2: Chitodex (10ml of succinyl chitosan + 300mg of dextran aldehyde) + Budesonide (Pulmicort) 2mg/4mL with oral antibiotics OR * Budesonide is incorporated into the gel complex 3. Control group: Oral antibiotics and will not receive any test gel post op (current standard practice) Oral antibiotics prescribed are as per standard post operative practice of investigator unless guided by previous swab results and contraindications (ie. adverse reactions). All patients will have 2 swabs taken by the surgeon under direct visualisation with rigid nasoendoscopy prior to their endoscopic sinus surgery for both bacterial culture as well as nasal microbiome analysis. At the end of the sinus surgery while the patient is still under general anaesthetic, the gel will be applied as a once-off prodedure by the operating surgeon. The gel is injected into the sinonasal cavity as post operative wound dressing using a luer lock pressure control syringe. All post operative and follow up instructions remain the same for patients in all cohorts. The patients will then be asked to return to the outpatient department at 2 weeks, 6 weeks and 6 months post operation (none different to usual practice). At each review they will have 2 sinus swabs taken and a recording of their endoscopic sinus examination. The endoscopic video examination will then be scored by a blinded clinician for infection (pus), oedema, granulation tissue, and crusting using validated Lund Kennedy Scale. In addition, patients will be asked to complete a self-directed symptom and comfort questionnaire at each time-point SNOT22 and Visual Analogue Scale. If on review visits any recruited patients have clinical signs and symptoms of sinus infection patient will be prescribed a rescue course of antibiotic (as per standard practice).
Sponsors
The Queen Elizabeth Hospital
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Selection/inclusion criteria: Patients who meet ALL of the following criteria will be offered inclusion in the study: (1) Patients undergoing ESS for CRS AND (2) Have who have had symptoms of chronic rhinosinusitis (nasal discharge, postnasal drip, nasal obstruction, facial pain and pressure, lack of sense of smell) that has been previously persistent for greater than 3 months AND (3) are over 18 years of age AND (4) are able to give written informed consent AND (5) are local patients who will be returning to this centre for postoperative follow-up care
Exclusion criteria
(1) allergy to shellfish, steroids or mupirocin (2) pregnant or breastfeeding (3) immunodeficient patients (patients on any immunosuppressive or immunomodulatory agent) (4) on other CYP450 inhibiting drugs (e.g. ketoconazole, ritonavir, atazanavir, clarithromycin, indinavir, itraconazole, nefazodone, nelfinavir, saquinavir and telithromycin) (5) liver disease
Outcome results
None listed