Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001327774
Ethics application status
Approved
Date submitted
5/08/2013
Date registered
2/12/2013
Date last updated
2/12/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
OSSIES: Obese Subcuticular Sutures versus Interrupted Evaluation at caesarean Section: a randomized control trial
Scientific title
OSSIES: Obese Subcuticular Sutures versus Interrupted Evaluation at caesarean Section: a randomized control trialon the effect of continuous subcuticular vs interrupted skin sutures on wound infection rates in obese patients at caesarean section
Secondary ID [1] 282950 0
nil
Universal Trial Number (UTN)
Trial acronym
OSSIES
Linked study record

Health condition
Health condition(s) or problem(s) studied:
post caesarean section wound in obese patients 289775 0
obesity
 290599 0
Condition category
Condition code
Reproductive Health and Childbirth 290120 290120 0 0
Childbirth and postnatal care
Infection 290991 290991 0 0
Other infectious diseases
Diet and Nutrition 290992 290992 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3.0 monocryl will be used in interrupted manner, 1-2cm apart long the caesarean section wound. they will be removed day 5-7 post op, this will take approximately ten minutes to carry out.
Intervention code [1] 287655 0
Treatment: Surgery
Comparator / control treatment
3.0 monocryl will be used in a subcuticular continuous manner to approximate the skin. this is a dissolvable suture and does not need to be removed. this will take approximately ten minutes to carry out.
Control group
Active

Outcomes
Primary outcome [1] 290151 0
at 6 weeks post op the principal investigator will call the women to enquire if they have been on antibiotics for a wound infection at any point
Timepoint [1] 290151 0
6 weeks post op
Secondary outcome [1] 304024 0
at the 6 week follow up phone call the principal investigator will also ask about any wound collections requiring drainage or dehiscence.
Timepoint [1] 304024 0
6 weeks post-op

Eligibility
Key inclusion criteria
BMI>30
Scheduled for elective caesarean section
Informed consent obtained
Minimum age
18 Years
Maximum age
60 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Age<18
Unable to give consent
BMI<30

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Patients with a BMI>30 will be approached in high-risk ante-natal clinic. They will be provided with the patient information and consent form and have the opportunity to ask the recruiting member of medical staff any questions they may have. they will also have the opportunity to take the consent form home to read and can consent on day of surgery.
Once signed, the consent will go onto their digital medical record. On the day of the caesarean section, the consent form will be printed alongside the operative consent form.
A computer generated randomized sequence of either interrupted or subcuticular sutures will be produced. A sequence of numbered envelopes will each contain the result of the randomization, indicating if the patient should have interrupted or continuous sutures. The envelopes will be stored in theatre. As each patient enters theatre they will have an envelope assigned to them that contains the random result: either subcuticular or interrupted sutures.The caesarean section will be carried out as per protocol. All patients included in this trial will have the subcutaneous fat layer closed with 2.0 vicryl. After closure of this layer, the envelope will be opened by the theatre scout and the corresponding suture type will be disclosed to the surgeon. The scout will instruct the surgeon on whether to perform subcuticular continuous suture or interrupted sutures
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A computer generated randomized sequence of either interrupted or subcuticular sutures will be produced. A sequence of numbered envelopes will each contain the result of the randomization, indicating if the patient should have interrupted or continuous sutures. The envelopes will be stored in theatre. As each patient enters theatre they will have an envelope assigned to them that contains the random result: either subcuticular or interrupted sutures.
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
Not yet recruiting
Date of first participant enrolment
Anticipated
9/12/2013
Actual
Date of last participant enrolment
Anticipated
2/02/2015
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
438
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 1386 0
Sunshine Hospital - St Albans
Recruitment postcode(s) [1] 7247 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 287726 0
Self funded/Unfunded
Name [1] 287726 0
Country [1] 287726 0
Primary sponsor type
Hospital
Name
sunshine hospital
Address
sunshine hospital
furlong road
st albans
Melbourne
Vic
3021
Country
Australia
Secondary sponsor category [1] 286466 0
None
Name [1] 286466 0
Address [1] 286466 0
Country [1] 286466 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289692 0
Melbourne Health human research and ethics committee
Ethics committee address [1] 289692 0
Office for Research
Level 6 East, Main Building
300 Grattan Street
The Royal Melbourne Hospital VIC 3050
Ethics committee country [1] 289692 0
Australia
Date submitted for ethics approval [1] 289692 0
05/08/2013
Approval date [1] 289692 0
30/10/2013
Ethics approval number [1] 289692 0
hrec2013.175

Summary
Brief summary
Throughout the world, rates of obesity and rates of caesarean sections are simultaneously increasingly. Moreover, women who have a body mass index (BMI) in the obese category ( that is >30) are much more likely to undergo caesarean section. These women there is a higher rate of wound infections and other wound complications such as wound breakdown and collection. In our study we propose that using interrupted stitches to close skin at caesarean section will reduce the rate of wound complications compared to using a continuous stitch.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 41934 0
Dr carole-anne whigham
Address 41934 0
Sunshine Hospital, Western Health
16/44 waterloo crescent
st kilda
3182
vic
Country 41934 0
Australia
Phone 41934 0
+61404644029
Fax 41934 0
Email 41934 0
c.a.whigham@doctors.net.uk
Contact person for public queries
Name 41935 0
Dr carole-anne whigham
Address 41935 0
c/o: womens health unit
sunshine hospital
furlong road
st albans
Vic 3021
Country 41935 0
Australia
Phone 41935 0
+61404644029
Fax 41935 0
Email 41935 0
drcwhigham@hotmail.com
Contact person for scientific queries
Name 41936 0
Dr carole-anne whigham
Address 41936 0
Sunshine Hospital, western health
16/44 waterloo crescent
st kilda
vic 3182
Country 41936 0
Australia
Phone 41936 0
+61404644029
Fax 41936 0
Email 41936 0
c.a.whigham@doctors.net.uk

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.