Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture.

Closing Uterine Incision During C-section Using Barbed Suture (Stratafix) or Vicryl Suture: a Randomized Control Study

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03159871

Enrollment

Registered

2017-05-19

Start date

2016-06-29

Completion date

2017-12-24

Last updated

2018-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cesarean Section

Keywords

Cesarean section, C- section, Suture

Brief summary

Detailed description

A Randomized prospective single blinded trial. The investigator seek to evaluate the surgical outcome of Stratafix barbed suture compared to standart Vicryl sutures in reducing the suturing time during C-Section. In addition, the need of additional sutures to control bleeding after the 2- layer closure will be estimated.These will be the primary outcome measures. The secondary outcome measures will be factors related to the blood loss at the time of the uterine closure, surgical complications, duration of hospital stay, postoperative infection (endometritis) and wound infection..

Interventions

DEVICEStratafix suture

Stratafix barbed sutures during C-Sections.

DEVICEVicryl suture

Standart Vicryl suture during C- Sections.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DEVICE_FEASIBILITY

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 42 Years

Healthy volunteers

Yes

Inclusion criteria

• Pregnant patients with an obstetrical indication for delivery by Cesarean section

Exclusion criteria

• Patients with blood clotting disorders.

Design outcomes

Primary

Measure	Time frame	Description
Time required for uterine closure.	From the beginning of first uterine suture till the last suture ending uterine incision complete closure and any additional hemostatic sutures if applicable. The estimated period of time is 8 minutes (average).	Time measured in minutes and seconds

Secondary

Measure	Time frame	Description
Blood loss during uterine closure	Estimated period of time is 4 days.	Intraoperative during uterine closure and by blood work during post-operative hospital stay

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026