Knotless Barbed Suture Closure of the Uterus at Caesarean Section

NCT06979687 | Completed

• 1 other identifier: 24/022
• Study Type: observational
• Target: 957
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Knotless barbed suture; caesarean section; caesarean delivery; caesarean birth

Outcome Measures

Primary Outcomes (1)

• Post-operative infection

  Whether antibiotics were prescribed for a surgical site infective complication.

  up to 6 weeks post-operative

Secondary Outcomes (4)

• operating time

  Intraoperative

• Blood loss

  In theatre during the operation

• Readmission

  up to 6 weeks post-operative

• Re-attendance as an outpatient

  up to 6 weeks post-operative

Other Outcomes (1)

• Operative complications

  Intraoperative and up to 6 weeks post-operatively

Study Arms (6)

Group 1 (Elective Caesareans undertaken using knotless barbed suture)

Elective caesareans undertaken using knotless barbed sutures. This included all cases without exception on the CI's regular operating list from January 2023 (after a positive trial period which resulted in this becoming the standard for the CI). n290.

Procedure: knotless barbed suture closure of the hysterotomy at caesarean section

Group 2 (Elective caesarean sections on a number of consultant lists using standard sutures SS)

May-August 2024 all cases on the respective lists n215

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

Group 3 (Emergency caesarean deliveries when KBS was used for closure of the hysterotomy)

Emergency caesarean deliveries (category 1-3 urgency - all except elective) using KBS January 2023-December 2024. n 107.

Procedure: knotless barbed suture closure of the hysterotomy at caesarean section

Group 4 (Emergency caesarean deliveries employing Standard sutures for closure of the hysterotomy)

All non-cat 4 CS using SS (May-August 2024) n 345

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

Group 5 (comprising all cases in group 1 and group 3)

All the KBS caesarean deliveries n 397

Procedure: knotless barbed suture closure of the hysterotomy at caesarean section

Group 6 (comprising group 2 and group 4)

All the SS cases n560

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

Interventions

knotless barbed suture closure of the hysterotomy at caesarean section PROCEDURE

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).

Group 1 (Elective Caesareans undertaken using knotless barbed suture); Group 3 (Emergency caesarean deliveries when KBS was used for closure of the hysterotomy); Group 5 (comprising all cases in group 1 and group 3)

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

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

Group 2 (Elective caesarean sections on a number of consultant lists using standard sutures SS); Group 4 (Emergency caesarean deliveries employing Standard sutures for closure of the hysterotomy); Group 6 (comprising group 2 and group 4)

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women having a caesarean section at James Cook University Hospital within the study period

You may qualify if:

• Women undergoing a caesarean section at the study hospital within the data collection period for that cohort - either with or without KBS depending on the cohort.

You may not qualify if:

• Not falling within the search criteria for a comparator group

Sponsors & Collaborators

• South Tees Hospitals NHS Foundation Trust: lead

Study Sites (1)

James Cook University Hospital

Middlesbrough, TS43BW, United Kingdom

Location

MeSH Terms

Conditions

Infections

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 20, 2025
• Study Start: November 1, 2022
• Primary Completion: February 11, 2025
• Study Completion: February 11, 2025
• Last Updated: May 29, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Feb 2025
• Access Criteria: Open access on CT.gov

Locations

GB (1)