ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12609001028291

Ethics application status

Approved

Date submitted

19/11/2009

Date registered

27/11/2009

Date last updated

27/11/2009

Type of registration

Prospectively registered

Titles & IDs

Public title

The effect of chitosan spray on bleeding and wound healing following tear duct surgery.

Scientific title

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.

Secondary ID [1]

Nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

To evaluate the effect of topical chitosan spray on haemostasis and wound healing following endoscopic dacryocystorhinostomy (endoDCR) without intubation.

Condition category

Condition code

Eye

Diseases / disorders of the eye

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

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).

Intervention code [1]

Treatment: Drugs

Comparator / control treatment

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. There will be no placebo. At the end of the procedure 1 ml of chitosan will be sprayed over the site of the surgery in the nose, in those randomised to receive it.

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).

Control group

Active

Outcomes

Primary outcome [1]

Comparison of the ostial patency and the positive endoscopic dye test at 3 months post operatively between the patients who received a single dose of 1ml chitosan (in spray form) at the time of surgery with those patients who received no spray (controls).

Timepoint [1]

3 months post surgery

Primary outcome [2]

The ostial patency rate in patients who underwent a single single dose of 1ml chitosan (in spray form) at the time of surgery should be better than patients who received no spray (controls). The ostial size should be bigger in the patients who underwent a single single dose of 1ml chitosan (in spray form) at the time of surgery than patients who received no spray (controls).

Patients will be assessed at each follow-up by perfroming a nasal endoscopic dye test in addition to syringing of the nasaolacrimal duct. 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).

Timepoint [2]

3 months post surgery

Secondary outcome [1]

Comparison of the symptomatic relief from epiphora at 3 months between the patients who received chitosan spray with those patients who received no spray (controls).

At each follow-up endoscopic dye test and syringing will be performed in the clinic. The patient will also be asked if the symptom of epiphora (watering) has resolved/ improved or remains unchanged.

Timepoint [1]

3 months post surgery

Secondary outcome [2]

The incidence of a watery eye following surgery should be less in the patients who underwent a single single dose of 1ml chitosan (in spray form) at the time of surgery than patients who received no spray (controls).

Patients will be assessed at each follow-up by perfroming a nasal endoscopic dye test in addition to syringing of the nasaolacrimal duct. 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).

Timepoint [2]

3 months post surgery

Eligibility

Key inclusion criteria

All patients over the age of 18 years, who are able to give written informed consent.

All patients with primary acquired nasolacrimal duct obstruction (PANLDO) as confirmed by clinical examination and radiological investigations (dacryocystography -/+ lacrimal scintigraphy).

Adequate renal function (glomerular filtration calculated by Cockcroft/Gault formula or measure urine creatinine clearance > or = to 50 mL/minute)

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

Key exclusion criteria

All patients with canalicular disease (obstruction/ stenosis), found either pre-operatively or at the time of surgery.

All patients with a history of previous nasolacrimal surgery (DCR).

All patients not willing to participate in the study.

Any patient with an allergy to shell/fish as this compound is a product of squid skeletons.

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

During the surgery, the patient will be computer randomised to receive either chitosan spray or no spray. At the end of the procedure chitosan will be sprayed over the site of the surgery in the nose, in those randomised to receive it.

Allocation is not concealed.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Random number generation by computer

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

Intervention assignment

Parallel

Other design features

Phase

Phase 2

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

4/01/2010

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

South Australian Institute of Ophthalmology

Address [1]

Discipline of Ophthalmology & Visual Sciences
South Australian Institute of Ophthalmology
Level 8
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Country [1]

Australia

Primary sponsor type

Hospital

Name

South Australian Institute of Ophthalmology

Address

Discipline of Ophthalmology & Visual Sciences

Level 8
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Royal Adelaide Hospital

Ethics committee address [1]

Discipline of Ophthalmology & Visual Sciences
South Australian Institute of Ophthalmology 
Level 8 
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

19/11/2009

Approval date [1]

Ethics approval number [1]

Summary

Brief 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.

Trial website

Trial related presentations / publications

1.	Zenk J, Karatzanis AD, Psychogios G, Franzke K, Koch M, Hornung J, Velegrakis GA, Iro H. Long-term results of endonasal dacryocystorhinostomy. Eur Arch Otorhinolaryngol. 2009 May 26. 
2.	Ben Simon GJ, Joseph J, Lee S, Schwarcz RM, McCann JD, Goldberg RA. External versus endoscopic dacryocystorhinostomy for acquired nasolacrimal duct obstruction in a tertiary referral center. Ophthalmology. 2005;112:1463-8.
3.	Tsirbas A, Davis G, Wormald PJ. Mechanical endonasal dacryocystorhinostomy versus external dacryocystorhinostomy. Ophthal Plast Reconstr Surg. 2004;20:50-6.
4.	Onerci M, Orhan M, Ogretmenoglu O, Irkeç M. Long-term results and reasons for failure of intranasal endoscopic dacryocystorhinostomy. Acta Otolaryngol. 2000;120:319-22.
5.	Hartikainen J, Antila J, Varpula M, et al. Prospective randomized comparison of endonasal endoscopic dacryocystorhinostomy and external dacryocystorhinostomy. Laryngoscope. 1998;108:1861-6.
6.	Tsirbas A, Wormald PJ. Endonasal dacryocystorhinostomy with mucosal flaps. Am J Ophthalmol. 2003;135:76-83. 
7.	Yuen KS, Lam LY, Tse MW, et al. Modified endoscopic dacryocystorhinostomy with posterior lacrimal sac flap for nasolacrimal duct obstruction. Hong Kong Med J. 2004;10:394-400. 
8.	Mann BS, Wormald PJ. Endoscopic assessment of the dacryocystorhinostomy ostium after endoscopic surgery. Laryngoscope. 2006;116:1172-4.
9.	Wormald PJ. Powered endoscopic dacryocystorhinostomy. Laryngoscope. 2002;112:69-72. 
10.	Smirnov G, Tuomilehto H, Teräsvirta M, et al. Silicone tubing is not necessary after primary endoscopic dacryocystorhinostomy: a prospective randomized study. Am J Rhinol. 2008;22:214-7. 
11.	Selig YK, Biesman BS, Rebeiz EE. Topical application of mitomycin-C in endoscopic dacryocystorhinostomy. Am J Rhinol. 2000;14:205-7.
12.	Deka A, Bhattacharjee K, Bhuyan SK, et al. Effect of mitomycin C on ostium in dacryocystorhinostomy. Clin Experiment Ophthalmol. 2006;34:557-61. 
13.	Athanasiadis T, Beule AG, Robinson BH, et al. Effects of a novel chitosan gel on mucosal wound healing following endoscopic sinus surgery in a sheep model of chronic rhinosinusitis. Laryngoscope. 2008;118:1088-94.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Kylie Dansie

Address

Discipline of Ophthalmology & Visual Sciences
South Australian Institute of Ophthalmology
Level 8
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Country

Australia

Phone

+61 8 8222 2732

Fax

+61 8 8222 2741

Kylie.Dansie@health.sa.gov.au

Contact person for scientific queries

Name

Paul S Cannon

Address

Discipline of Ophthalmology & Visual Sciences
South Australian Institute of Ophthalmology
Level 8
Royal Adelaide Hospital
North Terrace
Adelaide
SA 5000

Country

Australia

Phone

+61 8 8222 2729

Fax

+61 8 8222 2741

pscan05@yahoo.co.uk

No information has been provided regarding IPD availability

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No Supporting Document Provided

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