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Trial registered on ANZCTR
Registration number
ACTRN12611000170921
Ethics application status
Approved
Date submitted
11/02/2011
Date registered
11/02/2011
Date last updated
11/02/2011
Type of registration
Retrospectively registered
Titles & IDs
Public title
A blinded randomized controlled trial on the efficacy of post surgical debridement of sinus cavities on wound healing following endoscopic sinus surgery.
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Scientific title
A blinded randomized controlled trial on the efficacy of post surgical debridement of sinus cavities on wound healing following endoscopic sinus surgery.
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Secondary ID [1]
253592
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nil
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
CHRONIC RHINOSINUSITIS
261148
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Condition category
Condition code
Surgery
259306
259306
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0
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Surgical techniques
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Inflammatory and Immune System
259307
259307
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Debridement of randomised sinus cavity vs no debridement for contralteral sinus cavity
This occurs after sinus surgery to clean the operated site from blood and crusts
THIS OCCURS IN THE CLINIC. IT LASTS ABOUT 15 MINUTES. THE MECHANISM IS CLEANING BLOOD AND CRUSTS AS DISCUSSED ABOVE , WITH THE THOUGHT THAT THIS PREVENTS ADHESION FORMATION AND PAIN BUT THERE IS NO EVIDENCE THAT THIS WORKS - SEE BRIEF SUMMARY FIELD REGARDING THIS CLINICAL QUESTION AS REQUESTED.
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Intervention code [1]
258014
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Treatment: Surgery
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Comparator / control treatment
No debridement
No cleaning of the cavity occurs
SINCE NO DEBRIDEMENT OCCURS, OBVIOUSLY THERE IS NO INTERVENTION.
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Control group
Active
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Outcomes
Primary outcome [1]
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Adhesion and scar formation by video assessment of the sinus cavity by 2 blinded, independent observers
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Assessment method [1]
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Timepoint [1]
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3 months
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Secondary outcome [1]
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Quality of Life, using a validated VAS
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Assessment method [1]
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Timepoint [1]
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3 months
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Eligibility
Key inclusion criteria
CRS not responsive to maximum medical therapy
NO previous sinus surgery
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Sinus surgery for conditions other than CRS
Immunological, or congenital predisposition to CRS
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Computer generated randomisation of side to be debrided.
FInal result evaluated by surgeons blinded to which side has been debrided
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generation
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
1/11/2010
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
40
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
258479
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Hospital
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Name [1]
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The Queen Elizabeth Hospital
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Address [1]
258479
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Woodville Rd
Woodvillle South
5011
South Australia
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Country [1]
258479
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Australia
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Primary sponsor type
Individual
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Name
Professor Wormald
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Address
Woodville Rd
Woodvillle South
5011
South Australia
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Country
Australia
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Secondary sponsor category [1]
257620
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Individual
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Name [1]
257620
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Yuresh Naidoo
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Address [1]
257620
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Woodville Rd
Woodvillle South
5011
South Australia
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Country [1]
257620
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Australia
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
260456
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The Queen Elizabeth Hospital
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Ethics committee address [1]
260456
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Woodville Rd
Woodvillle South
5011
South Australia
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Ethics committee country [1]
260456
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Australia
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Date submitted for ethics approval [1]
260456
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Approval date [1]
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01/10/2010
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Ethics approval number [1]
260456
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Summary
Brief summary
Chronic sinusitis affects up to 20% of the population with a significant impact on quality of life for the sufferer. Endoscopic sinus surgery is currently the treatment of choice for chronic rhinosinusitis which fails to respond to medical therapy. This usually involves a combination of oral antibiotics, oral and topical steroids, and saline irrigation of the nose. The main complaint which patients have from this type of surgery is the discomfort and pain associated with debridement of the sino-nasal cavity following surgery. The main cause of failure of this surgery which may require revision surgery is poor wound healing with the formation of excess scar tissue in the form of bands between sides of the nose, called adhesions.
Regular wound debridement to achieve the best outcomes following ESS has been strongly advocated, but the basis is largely empirical. Experts in the field have called for regular cavity debridement. There is no standardized regime for post operative care amongst ESS surgeons. In some cases debridement as frequently as daily during the early healing phase has been used. Weekly debridement for the first few weeks until healing occurs is still commonly employed.
Sinus cavity debridement is uncomfortable and unpleasant for patients. It requires regular visits to the treating surgeon, with considerable cost implications on the patient and the health service. The literature as it stands is conflicting. There is only 1 pilot study investigating 17 pts in a non-blinded fashion. This pilot study demonstrated no significant difference in adhesions, however this was non-blinded and involved only 17 patients. There are studies that point to early debridement as key to limiting adhesion formation, whereas other studies show that minimal post-operative care is equally successful.
The aim of this study is to ascertain whether early debridement, with its related costs and patient discomfort, limits adhesion formation as evaluated by a blinded observer, via video-endoscopy at 3 months post surgery.
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Trial website
NA
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
32200
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Country
32200
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Phone
32200
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Fax
32200
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Email
32200
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Contact person for public queries
Name
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Yuresh Naidoo
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Address
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TQEH
28 Woodville Rd
WOodville
SA
5011
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Country
15447
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Australia
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Phone
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+618 82226000
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Fax
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+618-82227419
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Email
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[email protected]
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Contact person for scientific queries
Name
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Yuresh Naidoo
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Address
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As above
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Country
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Australia
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Phone
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+618 82226000
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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