None listed
Conditions
Brief summary
This research project is testing a new treatment for chronic rhinosinusitis by the use of a Chitosan-Dextran (Chitodex) gel mixed with medications to see if there is improved healing after sinus surgery and less infection. Chronic rhinosinusitis affects approximately 15% of the general population and is characterised by sinusitis symptoms persisting for more than 3 months. Patients who do not respond adequately to oral and topical steroids, antibiotics and nasal lavage require surgical management. The surgical procedure is termed endoscopic sinus surgery, and involves removing oedematous mucosa, pus and debris, as well as clearance of bony walls within the sinonasal cavity to open up blocked sinuses. Participants will receive the standard hospital information sheet about the sinus surgery, and will sign the standard hospital consent form for the sinus surgery. Purpose: The purpose of this research project is testing in sinus surgery whether adding two new antimicrobial agents (Deferiprone and Gallium-Protoporphyrin ) to a locally developed dissolvable nasal dressing (Chitodex gel) will improve the anti-microbial and wound-healing effects of Chitodex gel after sinus surgery compared to Chitodex alone. Procedure and Treatment: Under endoscopic guidance, each participant will have a sinus swab performed prior to surgery and then undergo the planned sinus surgery- Endoscopic sinus surgery (ESS) or ESS with frontal drill out At the end of the procedure, each participant will receive 10 ml of gel (Chitodex or Chitodex+ Deferiprone or Chitodex+ Deferiprone+ Gallium-Protoporphyrin) into one side of each of the three sinuses and the untreated side would be referred to as the control and receive routine standard of care. If the surgery is meant to produce a larger frontal sinus cavity (ESS with frontal drillout) 20 ml of gel would be applied or 20 ml of saline if you are in the control group. Post-operative care will proceed as per standard care after sinus surgery. Participants will return to the outpatient department 2 weeks, 6 weeks and 12 weeks after the surgery for post-operative review. During each visit we would perform a sinus swab and an endoscopic video recording of the sinuses. _x000C_The recorded video examination will then be scored by an independent clinician, unaware of your treatment, for infection (pus), oedema, granulation tissue, and crusting using a standardised scoring scales.
Interventions
FESS(Functional Endoscopic Sinus Surgery) alone (consisting 4 arms)
Arm 1- Dissolvable nasal dressing (Chitodex gel: CD-gel) alone- 10 ml of CD gel applied in the operated sinus, only once immediately at the end of surgery.
Arm 2-CD gel with the iron chelator Deferiprone(20mM/ml-)10 ml of CD gel with Deferiporone applied in the operated sinus, only once immediately at the end of surgery.
Arm 3- CD gel with the iron chelator Deferiprone(20mM/ml and the antibacterial agent Gallium-Protoporphyri
FESS(Functional Endoscopic Sinus Surgery) alone (consisting 4 arms) Arm 1- Dissolvable nasal dressing (Chitodex gel: CD-gel) alone- 10 ml of CD gel applied in the operated sinus, only once immediately at the end of surgery. Arm 2-CD gel with the iron chelator Deferiprone(20mM/ml-)10 ml of CD gel with Deferiporone applied in the operated sinus, only once immediately at the end of surgery. Arm 3- CD gel with the iron chelator Deferiprone(20mM/ml and the antibacterial agent Gallium-Protoporphyrin(250 µg/ml) -.10 ml of CD gel applied in the operated sinus, only once immediately at the end of surgery Arm 4 - CD gel + GaPP the antibacterial agent Gallium-Protoporphyrin(250 µg/ml) - 10 ml of CD gel with drug applied in the operated sinus, only once immediately at the end of surgery in FESS + drill out ( consisting 5 arms) 20 ml of CD gel applied in the frontal sinus, only once immediately at the end of surgery just as 4 arms of FESS group and Arm 5- Saline control All patients will undergo complete blood counts , Serum Iron levels and Liver funtion test before application. Post-operatively the serum drug levels of Deferiporone & Gallium Protoporphyrin willbe evaluated at 2 hrs, 6 hrs and 2 weeks . They will also be watched for development of any symptoms of photosensitivity.
Sponsors
The University of Adelaide
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
Participants who meet ALL of the following criteria will be offered inclusion in the study: Those 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 are over 18 years of age AND are able to give written informed consent AND are local and who will be returning to this centre for postoperative follow-up care AND are indicated to undergo endoscopic sinus surgery and willing to return at 2, 6 & 12 weeks post-op.
Exclusion criteria
1. allergy to shellfish 2. pregnant or breastfeeding 3. Hepatitis or blood disorders. 4.any drug allergy
Outcome results
None listed