The effect of chitosan spray on bleeding and wound healing following tear duct surgery.
A single centre, prospective, randomised, comparative interventional case series investigating the effect of topical chitosan spray on haemostasis and wound healing following endoscopic dacryocystorhinostomy (endoDCR) without intubation in patients with primary acquired nasolacrimal duct obstruction.
South Australian Institute of Ophthalmology
26 participants
Jan 4, 2010
Interventional
Conditions
Summary
This study is been carried out to investigate the effect of a new drug (Chitosan) on bleeding and wound healing following tear duct surgery that is performed through the nose (endoscopic dacryocystorhinostomy-endoDCR). If this new drug reduces scarring, it may have an effect on the successful outcome of the tear duct surgery (endoDCR). You have presented to the clinic because you have been troubled by a watering eye. The doctor has diagnosed that you have a blockage of your tear duct, which is the passage that links the eyelids to the inside of the nose and allows your tears to drain. The doctor will examine the inside of your nose and providing that there is adequate space, may offer to perform the surgery through the nose. This surgery is called an endonasal dacryocystorhinostomy (endoDCR). If there is not adequate space in the nose, then an external dacryocystorhinostomy (extDCR) may be offered to you. The dacryocystorhinostomy (DCR) operation attempts to create a new route for the drainage of tears between the tear sac and the lining of the nose. The operation can be performed either externally by cutting into the skin on the side of the nose or through the nose as in endonasal DCR. Failure in DCR surgery often results when scarring occurs at the new junction between the tear sac and the nose lining, which can then close over. There have been different steps taken during the operation to reduce this scarring, but it still occurs. A major bleed following this type of surgery can occur in about 2% of patients and is similar to both approaches. This study is looking at the effect of a drug called Chitosan on bleeding and wound healing. This drug is made of 2 components called dextran and chitosan. We will randomly assign patients to receiving either Chitosan or nothing at the end of their endonasal DCR surgery. The Chitosan comes in the form of a spray, which is squirted once over the site of the operation inside the nose. This does not need to be repeated. At each visit you will be examined as part of the routine post-operative care. The inside of the nose will be examined using a nasal endoscope and assessed for evidence of scarring. The clinic visits will be at 1 week, 4 weeks and 3 months following the surgery. There are no additional clinic dates for you as a result of this study.
Eligibility
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Interventions
Prospective, randomised, comparative interventional case series, comparing patients who receive chitosan spray at the end of endoDCR with patients who do not receive chitosan spray (controls). Chitosan is a compound made from substances called dextran and chitosan ( a product of squid skeletons), which are broken down by the body over a few days and excreted in the urine. There have been no reported adverse effects these substances. Chitosan is present in a number of “over-the-counter” medications marketed to reduce obesity. It is also a component of many cosmetics. All patients presenting with epiphora (watery eyes) will undergo ophthalmological and nasal endoscopic examination. Only patients whose epiphora is secondary to a blocked nasolacrimal duct as confirmed by clinical testing (examination and syringing of the tear ducts) in addition to radiological imaging (dacryocystography -/+ lacrimal scintigraphy) will be included in the study. The nasal endoscopic examination will be performed to assess suitability for the endoDCR approach. The surgery will be performed by a single surgeon (Professor Selva). The surgery will before in the Royal Adelaide Hospital eye theatre. During the surgery, the patient will be computer randomised to receive either chitosan spray or no spray. At the end of the procedure 1ml chitosan will be sprayed over the site of the surgery in the nose, in those randomised to receive it. There will only be a single dose of chitosan administered in the trial. Follow-up will be at 1 week, 4 weeks and 3 months. At each follow-up endoscopic dye test and syringing will be performed in the clinic. A grading chart for the endoscopic examination will also be completed at each clinic visit. The chart will record the presence of blood clots, crusting at the site of the surgery, evidence of infection in the nose, mucosal oedema (swelling of the nose lining) and granulation tissue in the nose (scar tissue).
Locations(1)
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ACTRN12609001028291