Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12606000445572
Ethics application status
Approved
Date submitted
8/10/2006
Date registered
17/10/2006
Date last updated
17/10/2006
Type of registration
Retrospectively registered

Titles & IDs
Public title
Wound Healing After Craniotomy
Scientific title
Wound Healing After Craniotomy : a randomised prospective trial comparing scalp clips to artery forceps as techniques of scalp haemostasis
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound healing after craniotomy of greater than 2 hours' duration. The craniotomy can be for any of the appropriate indications, such as intra-cranial tumour, aneurysm etc. 1418 0
Condition category
Condition code
Surgery 1514 1514 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
We are comparing healing of the scalp wounds when Aesculap Rainey clips are used on the wound edge to obtain scalp haemostasis (comparison intervention), to the results when artery forceps are used (control). These devices are applied during the operation (2 to many hours), and then removed prior to closure of the wound.
Intervention code [1] 1393 0
Treatment: Devices
Comparator / control treatment
Artery forceps are used
Control group
Active

Outcomes
Primary outcome [1] 2092 0
Wound healing, as defined by a specific original scoring system, designed by the investigators and validated in a pilot study. The wounds are scored for completeness of healing, hair loss, and presence of infection, minor or major, leading to a score of 3-15.
Timepoint [1] 2092 0
At 3 and 6 weeks post-op
Secondary outcome [1] 3606 0
Nil
Timepoint [1] 3606 0

Eligibility
Key inclusion criteria
All patients undergoing de novo supra-tentorial craniotomy which is expected to last at least 2 hours.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Children, posterior fossa craniotomies, re-do craniotomies, and past irradiation.

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)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
simple randomisation by dice
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
subjects and assessors will be blinded to the treatment group.
Phase
Phase 3
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/11/2004
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 1649 0
Hospital
Name [1] 1649 0
Monash Medical Centre
Country [1] 1649 0
Primary sponsor type
Individual
Name
Clinical Associate Professor R. Andrew Danks
Address
Country
Secondary sponsor category [1] 1458 0
University
Name [1] 1458 0
University Department of Surgery, Monash Medical Centre
Address [1] 1458 0
Country [1] 1458 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3100 0
Monash Medical Centre
Ethics committee address [1] 3100 0
Ethics committee country [1] 3100 0
Australia
Date submitted for ethics approval [1] 3100 0
Approval date [1] 3100 0
05/05/2004
Ethics approval number [1] 3100 0
04032C

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27620 0
Address 27620 0
Country 27620 0
Phone 27620 0
Fax 27620 0
Email 27620 0
Contact person for public queries
Name 10582 0
Clincal Associate Professor R. Andrew Danks
Address 10582 0
Department of Neurosurgery
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 10582 0
Australia
Phone 10582 0
+61 3 95942886
Fax 10582 0
Email 10582 0
[email protected]
Contact person for scientific queries
Name 1510 0
Clinical Associate Professor R. Andrew Danks
Address 1510 0
Department of Neurosurgery
Monash Medical Centre
246 Clayton Rd
Clayton VIC 3168
Country 1510 0
Australia
Phone 1510 0
+61 3 95942886
Fax 1510 0
Email 1510 0
[email protected]

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.