None listed
Conditions
Brief summary
The purpose of this study is to further develop a nasal dressing for use after endoscopic sinus surgery. The gel being use is called Chitodex (Chitosan-Dextran gel) and has already been shown to be effective in controlling blood loss and reducing adhesions after endoscopic sinus surgery. The effectiveness and safety of the gel has been demonstrated in numerous human and animal trials. We are trying to incorporate additional medications into the gel to further accentuate it's uses after endoscopic sinus surgery. The addition of budesonide has shown to reduce adhesions and inflammation after sinus surgery, thus reducing the failure rate of the operation and the chance a patient needs another procedure. This has been demonstrated in a clinical trial. We hypothesise that the addition of a local anaesthetic to the gel, known as ropivacaine, will reduce the pain and discomfort that patients typically experience after endoscopic sinus surgery.
Interventions
The intervention that is being trialled is a gel complex consisting of Chitosan-Dextran gel plus Budesonide plus Ropivacaine. 10mLs of this complex will be applied to the sinonasal cavity immediately following endoscopic sinus surgery by the surgeon. The complex will include the Chitosan-Dextran gel (5% Succinyl-Chitosan & 300mg Dextran-aldehyde), 1mL of 1% Ropivacaine (10mg/mL), 2mL of Budesonide (1mg). This complex will be applied twice to each patient (Once for each sinus side).
Sponsors
The Department of ENT, University of Adelaide
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with chronic rhinosinusitis undergoing endoscopic sinus surgery
Exclusion criteria
Pregnanct and/or breastfeeding. Allergy or previous adverse reaction to shellfish, anaesthetics or corticosteroids.
Outcome results
None listed