Trial Review

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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.
Scientific title
A blinded randomized controlled trial on the efficacy of post surgical debridement of sinus cavities on wound healing following endoscopic sinus surgery.
Secondary ID [1] 253592 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
CHRONIC RHINOSINUSITIS 261148 0
Condition category
Condition code
Surgery 259306 259306 0 0
Surgical techniques
Inflammatory and Immune System 259307 259307 0 0
Other inflammatory or immune system disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 258014 0
Treatment: Surgery
Comparator / control treatment
No debridement
No cleaning of the cavity occurs
SINCE NO DEBRIDEMENT OCCURS, OBVIOUSLY THERE IS NO INTERVENTION.
Control group
Active

Outcomes
Primary outcome [1] 262109 0
Adhesion and scar formation by video assessment of the sinus cavity by 2 blinded, independent observers
Timepoint [1] 262109 0
3 months
Secondary outcome [1] 273178 0
Quality of Life, using a validated VAS
Timepoint [1] 273178 0
3 months

Eligibility
Key inclusion criteria
CRS not responsive to maximum medical therapy
NO previous sinus surgery
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Sinus surgery for conditions other than CRS
Immunological, or congenital predisposition to CRS

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)
Computer generated randomisation of side to be debrided.
FInal result evaluated by surgeons blinded to which side has been debrided
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer random number generation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 258479 0
Hospital
Name [1] 258479 0
The Queen Elizabeth Hospital
Country [1] 258479 0
Australia
Primary sponsor type
Individual
Name
Professor Wormald
Address
Woodville Rd
Woodvillle South
5011
South Australia
Country
Australia
Secondary sponsor category [1] 257620 0
Individual
Name [1] 257620 0
Yuresh Naidoo
Address [1] 257620 0
Woodville Rd
Woodvillle South
5011
South Australia
Country [1] 257620 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 260456 0
The Queen Elizabeth Hospital
Ethics committee address [1] 260456 0
Woodville Rd
Woodvillle South
5011
South Australia
Ethics committee country [1] 260456 0
Australia
Date submitted for ethics approval [1] 260456 0
Approval date [1] 260456 0
01/10/2010
Ethics approval number [1] 260456 0

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.
Trial website
NA
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32200 0
Address 32200 0
Country 32200 0
Phone 32200 0
Fax 32200 0
Email 32200 0
Contact person for public queries
Name 15447 0
Yuresh Naidoo
Address 15447 0
TQEH
28 Woodville Rd
WOodville
SA
5011
Country 15447 0
Australia
Phone 15447 0
+618 82226000
Fax 15447 0
+618-82227419
Email 15447 0
yuresh@med.usyd.edu.au
Contact person for scientific queries
Name 6375 0
Yuresh Naidoo
Address 6375 0
As above
Country 6375 0
Australia
Phone 6375 0
+618 82226000
Fax 6375 0
Email 6375 0
yuresh@med.usyd.edu.au

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.