Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000143325
Ethics application status
Approved
Date submitted
13/03/2008
Date registered
20/03/2008
Date last updated
29/05/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Closing the skin and subcutaneous layers at Caesarean section to reduce wound complications
Scientific title
Skin and subcutaneous fascia closure in Caesarean section to reduce wound complications.
Secondary ID [1] 280577 0
nil
Universal Trial Number (UTN)
Trial acronym
CLOSURE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Wound complications after Caesarean section 2926 0
wound infection after caesarean section 286579 0
Condition category
Condition code
Reproductive Health and Childbirth 3062 3062 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each participant will be randomised to a) either closure or non closure of the subcutaneous fascia and b) closure of the skin with a subcuticular monofilament non absorbable versus absorbable suture. For both aspects of the procedure these are 2 currently used techniques so there is no true intervention only randomising to 2 currently used techniques. The design is therefore 2 x 2 factorial with resulting 4 possible groups. Follow up will be until 6 weeks.
Intervention code [1] 2655 0
Treatment: Surgery
Comparator / control treatment
There are no comparator/control treatments
Control group
Active

Outcomes
Primary outcome [1] 3945 0
Wound infection
Timepoint [1] 3945 0
Information will be collected by follow up phone call at 30days and subsequent medical record review or return of wound assessment forms from those who may have assessed the wound by day 30
Secondary outcome [1] 6626 0
Wound haematoma and seroma
Timepoint [1] 6626 0
Information will be collected by follow up phone call at 30days and subsequent medical record review or return of wound assessment forms from those who may have assessed the wound by day 30

Eligibility
Key inclusion criteria
Women undergoing a caesarean section by transverse suprapubic incision
Minimum age
No limit
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
known lethal fetal anomaly and planned midline skin incision

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)
sequentially numbered identically appearing treatment packs are taken from a locked box
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
randomisation by balanced variable blocks
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Factorial
Other design features
2 x 2 factorial design
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
720
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment postcode(s) [1] 608 0
5006

Funding & Sponsors
Funding source category [1] 3179 0
Charities/Societies/Foundations
Name [1] 3179 0
Royal Australian and New Zealand College of Obstetricians and Gynaecologists (RANZCOG) Research Foundation
Country [1] 3179 0
Australia
Primary sponsor type
University
Name
Discipline of Obstetrics and Gynaecology, The University of Adelaide
Address
72 King William Rd
North Adelaide South Australia 5006
Country
Australia
Secondary sponsor category [1] 2847 0
None
Name [1] 2847 0
Address [1] 2847 0
Country [1] 2847 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5160 0
Children, Youth and Women's Health Service (CYWHS) Human research ethics committee
Ethics committee address [1] 5160 0
72 King William Rd
North Adelaide South Australia 5006
Ethics committee country [1] 5160 0
Australia
Date submitted for ethics approval [1] 5160 0
Approval date [1] 5160 0
Ethics approval number [1] 5160 0

Summary
Brief summary
Caesarean section is a common operation and for different parts of the operation techniques vary widely between surgeons. Information is lacking about the best techniques and how different techniques may affect the mother's health. We propose to evaluate two methods of stitching up or closing the skin and whether to close or not to close the fatty layer beneath the skin. We want to know if these different methods cause differences in wound problems after birth and also whether there is a difference in pain and the mothers general physical and emotional health. We aim to examine these methods in approximately 700 women over a 2 year period and will follow them until 6 weeks after the birth.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28436 0
Address 28436 0
Country 28436 0
Phone 28436 0
Fax 28436 0
Email 28436 0
Contact person for public queries
Name 11593 0
Dr Rosalie Grivell
Address 11593 0
University of Adelaide
72 King William Rd
North Adelaide South Australia 5060
Country 11593 0
Australia
Phone 11593 0
+61 8 81617000
Fax 11593 0
Email 11593 0
rosalie.grivell@adelaide.edu.au
Contact person for scientific queries
Name 2521 0
Dr Rosalie Grivell
Address 2521 0
University of Adelaide
72 King William Rd
North Adelaide South Australia 5060
Country 2521 0
Australia
Phone 2521 0
+61 8 81617000
Fax 2521 0
Email 2521 0
rosalie.grivell@adelaide.edu.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
SourceTitleYear of PublicationDOI
EmbaseSkin and subcutaneous fascia closure at caesarean section to reduce wound complications: The closure randomised trial.2020https://dx.doi.org/10.1186/s12884-020-03305-z
N.B. These documents automatically identified may not have been verified by the study sponsor.