Reducing Surgical Site Infection in Caesarean Section: Is there a role for antibacterial sutures?

Does the use of antibacterial (Triclosan) impregnated sutures at the time of performing caesarean section reduce the incidence of surgical site infection in postpartum women when compared to standard sutures?

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12612000768897

Enrollment

550

Registered

2012-07-19

Start date

2012-08-01

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

This trial is hoping to find out if a new type of antibacterial-coated stitch will help to reduce the risk of infection in the wound after Caesarean Section delivery. At the time of Caesarean Section we will pick, by chance, half of the women in the study to receive the coated stitch in place of the routine non-antibacterial stitch when closing the skin and deeper layers but not the uterus (womb). All other aspects of the care relating to the Caesarean Section will remain unchanged. The follow-up and post-operative care will remain as standard. 30 days after the operation we will collect information from the patient’s midwife/LMC about whether she has had any signs or symptoms that might suggest infection in the wound. Treatment of any infection will not be altered or delayed because of the trial. We will use this information to find out if the antibacterial stitch reduces the risk of infection for women after Caesarean Section. We hypothosise that the antibacterial stitch will reduce the occurance of wound infection.

Interventions

Use of Triclosan-coated sutures for closure of rectus muscle sheath and skin at caesarean section. Closure of the rectus sheath and skin usually takes about 10 minutes but does vary from case to case depending on the patient and the operator.

Study design

Allocation

Randomised controlled trial

Primary purpose

Prevention

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Yes

Inclusion criteria

Elective, semi-elective and emergency caesarean sections in women seen and consented in an Antenatal Clinic or Antenatal Ward setting prior to presentation on the day of surgery. (E.g. including women undergoing emergency caesarean section during attempted vaginal birth after previous caesarean section if seen and consented in antenatal clinic on a prior occasion).

Exclusion criteria

Pre-existing Type 1 or 2 Diabetes (not Gestational diabetes which should resolve post-delivery and remove the increased risk of infection post-operatively).

Outcome results