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Knotless Barbed Suture Closure of the Uterus at Caesarean Section

NCT06979687 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 957

Last updated 2025-05-29

No results posted yet for this study

Summary

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.

Conditions

  • Caesarean Section
  • Caesarean Section; Infection

Interventions

PROCEDURE

knotless barbed suture closure of the hysterotomy at caesarean section

Use of Medtronic V-loc 180 suture (VL) for a 2 layer closure of the caesarean hysterotomy rather than the standard 2 layer closure using the 910 polyglactin suture (SS).

PROCEDURE

Standard 2 layer closure of caesarean hysterotomy using 910 polyglactin suture (SS)

Standard 2 layer closure using the 910 polyglactin suture (SS)

Sponsors & Collaborators

  • South Tees Hospitals NHS Foundation Trust

    lead OTHER

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-01
Primary Completion
2025-02-11
Completion
2025-02-11

Countries

  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06979687 on ClinicalTrials.gov