RecruitingPhase 1ACTRN12618000577213

Effect of novel drug with Chitodex gel on wound healing post endoscopic sinus surgery in the treatment of Chronic Rhinosinusitis (CRS)

Chitosan-dextran (Chitodex) gel with and without Deferiprone and Gallium-Protoporphyrin-wound healing and post operative outcomes in the treatment of Chronic Rhinosinusitis (CRS)


Sponsor

The University of Adelaide

Enrollment

90 participants

Start Date

Feb 14, 2018

Study Type

Interventional

Conditions

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. 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.


Eligibility

Sex: Both males and femalesMin Age: 18 Yearss

Plain Language Summary

Simplified for easier understanding

This study is testing a new wound treatment for people who have chronic sinusitis — a long-standing inflammation of the sinuses — and require sinus surgery. After sinus surgery, the healing process can be slow and complicated by bacterial infection, sometimes with bacteria that form protective films called biofilms that are resistant to standard antibiotics. Researchers are adding two antimicrobial agents (deferiprone and gallium-protoporphyrin) to an existing dissolvable nasal gel (Chitodex) to see if this combination improves healing and reduces infection after surgery. During surgery, one side of each patient's sinuses will receive the medicated gel while the other side serves as the control (no gel or standard Chitodex). Follow-up visits at 2, 6, and 12 weeks will assess healing using a camera examination of the sinuses and bacterial swabs. You may be eligible if you are 18 or older, have had chronic sinusitis symptoms for more than 3 months, are scheduled for endoscopic sinus surgery, and are able to attend follow-up appointments. People with shellfish allergies, pregnancy, hepatitis, blood disorders, or known drug allergies are not eligible.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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 immediat

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.


Locations(1)

The Queen Elizabeth Hospital - Woodville

SA, Australia

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ACTRN12618000577213