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Trial registered on ANZCTR


Registration number
ACTRN12616001206415
Ethics application status
Approved
Date submitted
2/07/2016
Date registered
31/08/2016
Date last updated
31/08/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Does the Alexis retractor increase the risk of blood splashes to surgeons' face.
Scientific title
Does the Alexis retractor increase the risk of blood splashes to surgeons' face during laparotomy surgeries.
Secondary ID [1] 289595 0
Nil known
Universal Trial Number (UTN)
U1111-1184-9824
Trial acronym
ALEXIS
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Laparotomy 299364 0
Condition category
Condition code
Surgery 299352 299352 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This is a randomised controlled single centre trial where surgeons will be asked to wear a clear plastic visor, in addition to protective clothing normally used during surgery. Surgeons performing open abdominal surgery at University Hospital Geelong will be asked to participate. Participation in this research will not affect the choice of procedure or care provided to patients. No samples will be collected at any time during this study. Surgeons will be randomly allocated either to use Alexis retractor or not to use it during their operations. Blood spatter caught on the surgeon’s visor will be quantified after surgical procedures involving the abdomen. Clear plastic visors will be examined on a black background. Macroscopic blood spatter will be graded by size and count, and whether the blood is dripping or not. Microscopic blood spatter will be counted. Counted blood droplets will be marked with a black marker to prevent double-counting. Results will then be compared for surgeries in which the Alexis Wound Retractor was used compared to those during which this instrument was not used. Surgeons participating in the study will be allowed to insert and remove the Alexis retractor in their usual method with no restriction to the style of insertion or time taken to remove it.
Intervention code [1] 295201 0
Treatment: Devices
Comparator / control treatment
Control group does not use Alexis retractor. Any other form of retracting device can be used during laparotomy.
Control group
Active

Outcomes
Primary outcome [1] 298821 0
Mask with visors used during the trial will be collected each day. Number of droplets on each mask will be counted. Droplets less than 1 mm will not be counted. Results will be tabulated for analysis at the end of the data collection period.
Timepoint [1] 298821 0
Masks will be collected at the end of each operating day and counted within 24hrs of the operation.
Secondary outcome [1] 325308 0
none
Timepoint [1] 325308 0
none

Eligibility
Key inclusion criteria
All laparotomy surgeries
Minimum age
10 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
If the use of or without the use of Alexis retractors compromise the safety of the operation, such a case will be excluded.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Safety
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/07/2016
Date of last participant enrolment
Anticipated
30/06/2017
Actual
Date of last data collection
Anticipated
30/06/2017
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 6089 0
Barwon Health - Geelong Hospital campus - Geelong
Recruitment postcode(s) [1] 13550 0
3220 - Geelong

Funding & Sponsors
Funding source category [1] 293982 0
Hospital
Name [1] 293982 0
Geelong Barwon Health Hospital
Country [1] 293982 0
Australia
Primary sponsor type
Hospital
Name
Geelong Hospital (Barwon Health)
Address
University Hospital Geelong
Bellerine Street (main entrance)
Ryrie Street (emergency entrance)

PO Box 281
Geelong VIC 3220
General enquiries: (03) 4215 0000
Country
Australia
Secondary sponsor category [1] 292800 0
None
Name [1] 292800 0
Address [1] 292800 0
Country [1] 292800 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295400 0
Barwon Health Research Administration Officer Research Ethics, Governance & Integrity (REGI) Unit
Ethics committee address [1] 295400 0
PO Box 281 Geelong Victoria 3220
Ethics committee country [1] 295400 0
Australia
Date submitted for ethics approval [1] 295400 0
01/03/2016
Approval date [1] 295400 0
17/06/2016
Ethics approval number [1] 295400 0
15/162

Summary
Brief summary
Does the Alexis Wound Retractor increase the risk of conjunctival contamination from blood splashes during surgery?

Background: Blood splashes to the face/ eyes are a recognised risk to the surgeon and assistants

Alexis retractor
is commonly used during laparotomy, laparoscopic operations and caesareans
Increase exposure, protect wound, reduce wound infection

Concern: blood droplets spraying into the air/ face/ eyes during removal

Aim: Assess whether there is an increased risk of blood splashes during operations when the Alexis retractor is used

Design: Double blinded randomised trial including all abdominal operations in which Alexis retractor may be used
Surgeons and assistants will wear visors
Randomised to Alexis or no Alexis
End point: number of blood splashes on visors
Power calculations 44 in each group
Aim to recruit 50 in each group
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 67134 0
Dr Sally Ooi
Address 67134 0
Geelong Hospital. Dept of General Surgery.
Bellarine St. Geelong VIC 3220
Country 67134 0
Australia
Phone 67134 0
+61 3 42150000
Fax 67134 0
Email 67134 0
[email protected]
Contact person for public queries
Name 67135 0
Sally Ooi
Address 67135 0
Geelong Hospital. Dept of General Surgery.
Bellarine St. Geelong VIC 3220
Country 67135 0
Australia
Phone 67135 0
+61 3 42150000
Fax 67135 0
Email 67135 0
[email protected]
Contact person for scientific queries
Name 67136 0
Sally Ooi
Address 67136 0
Geelong Hospital. Dept of General Surgery.
Bellarine St. Geelong VIC 3220
Country 67136 0
Australia
Phone 67136 0
+61 3 42150000
Fax 67136 0
Email 67136 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

Current supporting documents:


Updated to:
Doc. No.TypeCitationLinkEmailOther DetailsAttachment
23441Informed consent form   
23442Ethical approval   
23443Study protocol   

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.