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Trial registered on ANZCTR


Registration number
ACTRN12609000021279
Ethics application status
Approved
Date submitted
12/11/2008
Date registered
12/01/2009
Date last updated
21/10/2014
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparing two techniques of skin closure, purse string closure and linear closure, in terms of the incidence of surgical site infection in adults undergoing elective reversal of ileostomy
Scientific title
Randomised control trial of adults undergoing elective reversal of ileostomy, comparison of skin closure techniques, comparing purse string closure with linear closure in terms of the incidence of surgical site infection.
Secondary ID [1] 285530 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Surgical site infection 3971 0
Condition category
Condition code
Infection 4168 4168 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Skin closure technique for ileostomy reversal, purse string closure. This intervention is used once on each participant in this arm of the study. The intervention involves the technique used for skin closure during the elective operation to reverse the participants ileostomy. This intervention is definitive method of closure of the skin after reversal of the participants ileostomy, it is a permanent procedure. The follow up period for detection of surgical site infection (the primary outcome measure) is 30 days post surgery. Patients will be followed up for as much as a further 2 years to assess the secondary outcome measure, cosmetic result. "Purse string closure" differs from the comparator treatment "linear closure" in terms of the technique use for closure of the skin following the reversal of ileostomy. "Purse string closure" involves a suturing technique that draws the skin together in a circular fashion, in contrast to "linear closure" which abuts the edges of the skin defect, and sutures them closed in a traditional linear fashion.
Intervention code [1] 3689 0
Treatment: Surgery
Comparator / control treatment
Skin closure technique for ileostomy reversal, linear closure. This intervention is used once on each participant in this arm of the study. The intervention involves the technique used for skin closure during the elective operation to reverse the participants ileostomy. This intervention is definitive method of closure of the skin after reversal of the participants ileostomy, it is a permanent procedure. The follow up period for detection of surgical site infection (the primary outcome measure) is 30 days post surgery. Patients will be followed up for as much as a further 2 years to assess the secondary outcome measure, cosmetic result. "Linear closure" differs from the comparator treatment "purse string closure" in terms of the technique use for closure of the skin following the reversal of ileostomy. "Linear closure" abuts the edges of the skin defect, and sutures them closed in a traditional linear fashion, in contrast to "Purse string closure" which involves a suturing technique that draws the skin together in a circular fashion.
Control group
Active

Outcomes
Primary outcome [1] 5062 0
Surgical site infection as defined by the Ceters for Disease Control (CDC).
Timepoint [1] 5062 0
Infection occurring with in 30 days of completion of surgery. Participants will be assessed for the presence of surgical site infection, on days 1,2, and 3 post surgery, 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 train observer.
Secondary outcome [1] 8514 0
Cosmetic result. Assessment made by independent expert panel, using a visual analogue scale assessment tool.
Timepoint [1] 8514 0
Scar assessed with in 12 to 24 months of surgery. The timing of this assessment will be determined by the timing of follow up visits with the treating surgeon. Assessment will co-ordinate with these visits. (N.B the 30 day time frame for assessment of the presence of surgical site infection dose not relate to the time frame for this outcome measure).

Eligibility
Key inclusion criteria
Adults undergoing elective reversal of ileostomy
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 time of scheduling of elective reversal of ileostomy, allocation to 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, 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 blinded assistant.
Masking / blinding
Open (masking not 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
1/11/2006
Actual
1/11/2006
Date of last participant enrolment
Anticipated
Actual
28/12/2007
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] 4155 0
Self funded/Unfunded
Name [1] 4155 0
Stephen Smith
Country [1] 4155 0
Australia
Funding source category [2] 4289 0
Self funded/Unfunded
Name [2] 4289 0
Brian Draganic
Country [2] 4289 0
Australia
Primary sponsor type
Individual
Name
Stephen Smith
Address
G7, Ground Floor Medical Suites Newcastle Private Hospital, Lookout Rd, New Lampton Heights, NSW 2305
Country
Australia
Secondary sponsor category [1] 3736 0
Individual
Name [1] 3736 0
Brian Draganic
Address [1] 3736 0
G7, Ground Floor Medical Suites Newcastle Private Hospital, Lookout Rd, New Lampton Heights, NSW 2305
Country [1] 3736 0
Australia
Secondary sponsor category [2] 3930 0
None
Name [2] 3930 0
Address [2] 3930 0
Country [2] 3930 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6218 0
Hunter New England Human Research Ethics Comitee
Ethics committee address [1] 6218 0
Ethics committee country [1] 6218 0
Australia
Date submitted for ethics approval [1] 6218 0
26/05/2006
Approval date [1] 6218 0
28/06/2006
Ethics approval number [1] 6218 0
06/06/28/5.04

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

Contacts
Principal investigator
Name 29124 0
Dr Stephen Smith
Address 29124 0
Division of Surgery
John Hunter Hospital
Lookout Road
New Lambton Heights
NSW 2305
Country 29124 0
Australia
Phone 29124 0
+61 2 49855153
Fax 29124 0
Email 29124 0
stephen.smith@hnehealth.nsw.gov.au
Contact person for public queries
Name 12281 0
Rosemary Carroll
Address 12281 0
Division of Surgery
John Hunter Hospital
Lookout Road
New Lambton Heights
NSW 2305
Country 12281 0
Australia
Phone 12281 0
+61 2 49855153
Fax 12281 0
+ 61 2 49214274
Email 12281 0
rosemary.carroll@hnehealth.nsw.gov.au
Contact person for scientific queries
Name 3209 0
Stephen Smith
Address 3209 0
G7, Ground Floor Medical Suites Newcastle Private Hospital, Lookout Rd, New Lampton Heights, NSW 2305
Country 3209 0
Australia
Phone 3209 0
+612 49563243
Fax 3209 0
+612 49563246
Email 3209 0
stephen.smith@hnehealth.nsw.gov.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.