ANZCTR - Registration

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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]

nil

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

CHRONIC RHINOSINUSITIS

Condition category

Condition code

Surgery

Surgical techniques

Inflammatory and Immune System

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]

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]

Adhesion and scar formation by video assessment of the sinus cavity by 2 blinded, independent observers

Timepoint [1]

3 months

Secondary outcome [1]

Quality of Life, using a validated VAS

Timepoint [1]

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?

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

Hospital

Name [1]

The Queen Elizabeth Hospital

Address [1]

Woodville Rd
Woodvillle South
5011
South Australia

Country [1]

Australia

Primary sponsor type

Individual

Name

Professor Wormald

Address

Woodville Rd
Woodvillle South
5011
South Australia

Country

Australia

Secondary sponsor category [1]

Individual

Name [1]

Yuresh Naidoo

Address [1]

Woodville Rd
Woodvillle South
5011
South Australia

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The Queen Elizabeth Hospital

Ethics committee address [1]

Woodville Rd
Woodvillle South
5011
South Australia

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

Approval date [1]

01/10/2010

Ethics approval number [1]

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

Address

Country

Phone

Fax

Contact person for public queries

Name

Yuresh Naidoo

Address

TQEH
28 Woodville Rd
WOodville
SA
5011

Country

Australia

Phone

+618 82226000

Fax

+618-82227419

yuresh@med.usyd.edu.au

Contact person for scientific queries

Name

Yuresh Naidoo

Address

As above

Country

Australia

Phone

+618 82226000

Fax

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.

Trial Review

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Documents added manually

Documents added automatically