NCT06979687

Knotless Barbed Suture Closure of the Uterus at Caesarean Section

Completed Last updated 29 May 2025

What this trial tests

trial testing knotless barbed suture closure of the hysterotomy at caesarean section in Caesarean Section in 957 participants. Completed in 11 February 2025.

Timeline

1 November 2022

Primary endpoint
11 February 2025

11 February 2025

Quick facts

Lead sponsor	South Tees Hospitals NHS Foundation Trust
Status	Completed
Study type	OBSERVATIONAL
Enrollment	957
Start date	1 November 2022
Primary completion	11 February 2025
Estimated completion	11 February 2025
Sites	1 location across United Kingdom

Drugs / interventions tested

• knotless barbed suture closure of the hysterotomy at caesarean section
• Standard 2 layer closure of caesarean hysterotomy using 910 polyglactin suture (SS)

Conditions studied

• Caesarean Section — all drugs for Caesarean Section →
• Caesarean Section; Infection — all drugs for Caesarean Section; Infection →

Sponsor

South Tees Hospitals NHS Foundation Trust

Who can join

Eligibility, female only, with Caesarean Section or Caesarean Section; Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Caesarean section (CS) is an increasingly common mode of delivery. The way in which this operation is carried out is important as it affects millions of women each. In recent years use of a 'self-retaining' suture or thread for closure of the uterine closure has become a recognised approach with a proven safety record. These sutures are known as knotless barbed sutures (KBS) as the unidirectional barbs on the surface of the suture hold the suture in the tissue without the need for knots. These sutures can be used instead of the usual 'smooth' suture which requires knots at the angles. There are high-level level data that CS are quicker and on average need fewer additional stitches to control blood loss when KBS are used. There is additional evidence of a potential reduction in problems with healing of the uterus with KBS, it is thought that this might lead to a lower risk of problems in repeat CS as the chance of the placenta implanting into the scar might be lower. At present this evidence is based on ultrasound surveillance of scar appearance which is an indirect measure. The real risk difference will need to be explored with the examination of real world outcomes over the coming years.

There is currently no published data on KBS for uterine closure at caesarean from the UK. This cohort, although retrospective, is adequately controlled, shows excellent outcomes and signals a potential marked reduction in infectious morbidity. This potentially means a better patient experience as well as a large cost saving because of reduced re-admission rates. These data were collected as part of a service improvement project but the generalisable nature of our findings mean the finding are research and should be published.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.