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Trial registered on ANZCTR


Registration number
ACTRN12609000020280
Ethics application status
Approved
Date submitted
31/12/2008
Date registered
12/01/2009
Date last updated
8/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing the use of a "wound protector" with traditional retraction techniques, in terms of the incidence of surgical site infection in adults undergoing elective open colorectal resection surgery.
Scientific title
Randomised control trial of adults undergoing elective open colorectal resection, comparing the use of a "wound protector" with traditional retraction techniques in terms of the incidence of surgical site infection.
Secondary ID [1] 251722 0
N/A
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site infection in colorectal resection. 3969 0
Condition category
Condition code
Infection 4166 4166 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Method of retraction of sides of surgical incision to expose operation field in open elective colorectal resection, "wound protector". This intervention is used once on each participant in this arm of the study. The intervention involves the use of a "wound protector" for the retraction of the sides of the incision to expose the operation field. The intervention is a temporary measure, it is used only for the duration of the surgical procedure, it is removed immediately before closure of the surgical incision. The follow up period for the detection of surgical site infection (the primary outcome measure) is 30 days post surgery. The use of a "wound protector" differs from the comparator technique "traditional retraction techniques" in terms of the technique used to retract the sides of the surgical incision to expose the operation field. The use of a "wound protector" involves the insertion of one end of a plastic cylindrical device into the surgical incision, the device is then wound taut to retract the sides of the incision and expose the operation field. The "wound protector" is removed at the end of the operation, immediately prior to closure of the surgical incision. "Traditional retraction techniques" involves the use of traditional metal surgical retractors to retract the sides of the surgical incision and expose the operation field. These retractors are removed immediately prior the closure of the surgical incision.
Intervention code [1] 3687 0
Treatment: Surgery
Comparator / control treatment
Method of retraction of sides of surgical incision to expose operation field in open elective colorectal resection, "traditional retraction techniques". This intervention is used once on each participant in this arm of the study. The intervention involves the use of a "traditional retraction techniques" for the retraction of the the sides of the incision to expose the operation field. The intervention is a temporary measure, it is used only for the duration of the surgical procedure, all retraction devices are removed immediately before closure of the surgical incision. The follow up period for the detection of surgical site infection (the primary outcome measure) is 30 days post surgery. The use of a "traditional retraction techniques" differs from the comparator technique "wound protector" in terms of the technique used to retract the sides of the surgical incision to expose the operation field. "Traditional retraction techniques" involve the use of traditional metal surgical retractors to retract the sides of the surgical incision and expose the operation field. These retractors are removed immediately prior the the closure of the surgical incision. The use of a "wound protector" involves the insertion of a one end of plastic cylindrical device into the surgical incision, the device is then wound taught to retract the sides of the incision and expose the operation field. The "wound protector" is removed at the end of the operation, immediately prior to closure of the surgical incision.
Control group
Active

Outcomes
Primary outcome [1] 5250 0
Surgical site infection as defined by the Centres for Disease Control (CDC). This outcome will be assessed by a blinded, independent, surgeon trained observer. This observer will assess the wound at regular intervals in the 30 days following surgery. Clinical criteria will be used to determine the presence of a surgical site infection (SSI).
Timepoint [1] 5250 0
Infection occurring with in 30 days of completion of surgery. Participants will be assessed for the presence of surgical site infection on post operative days 3 and 5, and on the day they are discharged from hospital and at the time of their follow up appointment with their treating surgeon. All assessments will be made by an independent surgeon trained observer.
Secondary outcome [1] 8849 0
Not applicable to this study, there is only one outcome measure.
Timepoint [1] 8849 0
Not applicable

Eligibility
Key inclusion criteria
Adults undergoing elective open colorectal resection.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Those under 18, those unable to make informed consent to take part in the trial.

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)
Subjects enrolled at the time of scheduling of elective open colorectal resection surgery. Allocation of treatment group was achieved by the use of sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
All randomisation envelopes required for the trial were filled and sealed prior to the commencement of the trial. These envelopes were then randomly assigned to participants, and opened by the surgeon at the time of surgery. Simple randomisation was achieved by creation of equal numbers of active and control envelopes, which were then sealed, shuffled and sequentially assigned to study participants by a blinded assistant.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
320
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4341 0
Self funded/Unfunded
Name [1] 4341 0
Brian Draganic
Country [1] 4341 0
Australia
Funding source category [2] 4363 0
Self funded/Unfunded
Name [2] 4363 0
Stephen Smith
Country [2] 4363 0
Australia
Primary sponsor type
Individual
Name
Brian Draganic
Address
G7, Ground Floor Medical Suites Newcastle Private Hospital, Lookout Rd, New Lambton Heights, NSW, 2305
Country
Australia
Secondary sponsor category [1] 3910 0
Individual
Name [1] 3910 0
Stephen Smith
Address [1] 3910 0
G7, Ground Floor Medical Suites Newcastle Private Hospital, Lookout Rd, New Lambton Heights, NSW, 2305
Country [1] 3910 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6398 0
Hunter New England Human Research Ethics Comitee
Ethics committee address [1] 6398 0
Ethics committee country [1] 6398 0
Australia
Date submitted for ethics approval [1] 6398 0
Approval date [1] 6398 0
22/11/2006
Ethics approval number [1] 6398 0
06/11/22/5.04

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

Contacts
Principal investigator
Name 29122 0
Address 29122 0
Country 29122 0
Phone 29122 0
Fax 29122 0
Email 29122 0
Contact person for public queries
Name 12279 0
Brian Draganic
Address 12279 0
G7, Ground Floor Medical Suites Newcastle Private Hospital, Lookout Rd, New Lampton Heights, NSW, 2305
Country 12279 0
Australia
Phone 12279 0
+612 49563244
Fax 12279 0
+612 49563246
Email 12279 0
helen@bdss.com.au
Contact person for scientific queries
Name 3207 0
Brian Draganic
Address 3207 0
G7, Ground Floor Medical Suites Newcastle Private Hospital, Lookout Rd, New Lampton Heights, NSW, 2305
Country 3207 0
Australia
Phone 3207 0
+612 49563244
Fax 3207 0
+612 49563246
Email 3207 0
helen@bdss.com.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.