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Closing the skin and subcutaneous layers at Caesarean section to reduce wound complications

Skin and subcutaneous fascia closure in Caesarean section to reduce wound complications.

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12608000143325
Acronym
CLOSURE
Enrollment
720
Registered
2008-03-20
Start date
2008-04-01
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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.

Sponsors

Discipline of Obstetrics and Gynaecology, The University of Adelaide
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Factorial
Primary purpose
Treatment
Masking
Blinded (masking used)

Eligibility

Sex/Gender
All
Age
0 to No maximum
Healthy volunteers
No

Inclusion criteria

Women undergoing a caesarean section by transverse suprapubic incision

Exclusion criteria

known lethal fetal anomaly and planned midline skin incision

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 17, 2026