RecruitingPhase 2ACTRN12608000143325

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.

Sponsor

Discipline of Obstetrics and Gynaecology, The University of Adelaide

Enrollment

720 participants

Start Date

Apr 1, 2008

Study Type

Interventional

Conditions

wound infection after caesarean section Wound complications after Caesarean section

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.

Eligibility

Sex: Females

Plain Language Summary

Simplified for easier understanding

This study is comparing different techniques for closing the skin and the fatty layer beneath the skin at the end of a Caesarean section (C-section). Different surgeons use different stitching methods, and there is limited evidence about which approach leads to fewer wound problems after surgery. This study will look at two methods for closing the skin and whether closing the fatty (subcutaneous) tissue layer makes a difference to wound healing, pain, and recovery in the weeks after birth. You may be eligible if: - You are a woman having a Caesarean section with a horizontal (transverse) incision just above the pubic area You may NOT be eligible if: - Your baby has a known severe, life-threatening abnormality - A vertical (midline) skin incision is planned instead Talk to your doctor about whether this trial might be right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

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.

Locations(1)

Australia

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ACTRN12608000143325