None listed
Conditions
Brief summary
Chronic rhinosinusitis (CRS) is a heterogeneous, multifactorial disease defined by sinonasal inflammation persisting more than 12 weeks. According to the Australian National Health Survey, in 2007-2008, 9.2% of the Australian population suffer from CRS. Along with sinonasal symptoms, patients frequently suffer with low mood, poor sleep and fatigue leading to significant direct and indirect costs to the health system. Despite the prevalence of the condition in the community and the burden both physically and financially, there is an ongoing search for an efficient and practical method to deliver ongoing treatment. The recent International Consensus Statement on the treatment of CRS include nasal saline irrigation and intranasal corticosteroid sprays/drops with the addition of a short course of oral corticosteroids for the CRS with nasal polyps (CRSwNP) subgroup. Topical therapy offers the benefits of high local concentrations without the systemic side effects, however in unoperated sinuses, delivery to the sinus mucosa is limited and less than 2% of the irrigated volume reaches the sinuses. Endoscopic sinus surgery (ESS) is essential to allow topical treatment to effectively reach the sinus cavities and is the treatment of choice in patients who fail to respond to appropriate medical therapy (AMT). The intention of ESS is to restore natural sinus ventilation and drainage pathways, relieve nasal obstruction with the preservation of mucosa, and ultimately allow CRS treatment to be de-escalated from systemic to topical treatments for long-term management. Topical steroids are an integral component of postoperative care in ESS. There is high-level evidence supporting their use, which has been shown to significantly improve patient’s self-reported symptoms and endoscopic scores at 6 & 12 months. In the clinical setting, steroids are mixed into high volume washes for delivery. Unfortunately, these devices have short mucosal contact time and require daily use. Ideal drug preparation should be delivered in a manner to optimise mucosal contact time with steady absorption & minimal wastage. Mucoadhesive, thermoresponsive in situ gelling systems (solgels) pose a potential vector for drug delivery. These polymer-based gels can be formulated to rapidly transform in situ from a liquid to gel once at sinonasal temperature and slowly release a drug to the target tissue. Recently, these soluble gels have been analysed ex-vivo in human nasal tissue and demonstrated prolonged mucosal contact time and sustained release of dexamethasone. Establishing the viability of these gels in-vivo opens an innovative method for drug delivery to the sinonasal mucosa with potential to treat a broad range of sinus conditions. This aim of this trial is to assess the use of solgels as a vector to deliver steroid to surgically opened sinus cavities. Assessment of delivery to sinuses, residence time & local side effects will be the primary areas of interest.
Interventions
The study involves the application of a solgel containing dexamethasone to previously opened sinus cavities. The solgel will be prepared at the Princess Alexandra Hospital in the Pharmacy department using techniques described by Pandey et al with blue food dye added to aid contrast between mucosal tissue.
Solgel consists of:
- Poloxamer 407 16% w/w
- Glycerin 3% w/w
- Propylparaben 0.03% w/w
- Polyvinyl alcohol 0.03% w/w
- Polycarbophil 0.02% w/w
- Dexamethasone 21-phosphate sodium salt 0.1% w
The study involves the application of a solgel containing dexamethasone to previously opened sinus cavities. The solgel will be prepared at the Princess Alexandra Hospital in the Pharmacy department using techniques described by Pandey et al with blue food dye added to aid contrast between mucosal tissue. Solgel consists of: - Poloxamer 407 16% w/w - Glycerin 3% w/w - Propylparaben 0.03% w/w - Polyvinyl alcohol 0.03% w/w - Polycarbophil 0.02% w/w - Dexamethasone 21-phosphate sodium salt 0.1% w/w - water soluble blue dye Participants will be recruited from Greenslopes Private hospital from the two supervising Otolaryngology Head and Neck (OHN) surgeons outpatients. They will be eligible if they are at least 6 weeks or more post endoscopic sinus surgery and had at least either their maxillary or ethmoid sinuses opened surgically. They will be approached at their postoperative follow up appointment by the treating consultant. If they are interested in participating in the trial will be contacted by the primary investigator to discuss the trial and obtain consent. The trial will be conducted at the Princess Alexandra Hospital in the OHN surgery outpatient department. Each participant will receive three actuations (100 micrograms/actuation) of Co-phenylcaine nasal spray (ENT Technologies, Melbourne) to each nostril to anaesthetise and decongest the nasal cavity prior to solgel administration. Under direct vision using a rigid endoscope (Storz), solgel will be applied to the surgically opened sinus cavities of the maxilla and/or ethmoid and/or sphenoid sinus using a syringe device. A photo will be taken before and after the solgel application. All images taken throughout will be saved onto the Karl Storz system as a study number and transferred to an encrypted USB. The maxillary sinus and/or sphenoid cavity will have 2 ml of solgel applied to the posterior wall while the ethmoid cavity will have 1ml applied. The cavities will be assessed again in 5 minutes with the rigid endoscope to assess the distribution. The patient will then be reviewed the following day and have their sinuses re-examined to assess for remaining gel. If the gel is still present, they will be reviewed again at day 5 to assess for the presence of the solgel. Patients with diseased sinuses will have their sinuses graded independently by a sinus surgeon using the Modified Lund Mackay postoperative endoscopy score if they are assessed at the day 5 visit to assess for any improvement.
Sponsors
Angelica Lynch
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
i. Above 18 years of age ii. Currently fit and healthy iii. Available for required follow up iv. Previous endoscopic sinus surgery >6 weeks ago
Exclusion criteria
Allergies to any of the medications being used in the trial
Outcome results
None listed