Study to Compare Suture Material in Closure of Uterine Incision in Cesarian Section

Single-blinded Prospective Trial Comparing Quantitive Blood Loss, Operative Time, and Post Operative Pain Using Stratafix Barbed Suture in Cesarian Section to the Use of Traditional Suture Material

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02517710

Acronym

Stratafix

Enrollment

100

Registered

2015-08-07

Start date

2014-04-30

Completion date

2016-12-31

Last updated

2018-08-10

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

Conditions

Hysterotomy Closure

Brief summary

Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures.

Detailed description

Cesarean section is one of the most common medical procedures women of child bearing age undergo, in the United States and the world. This trial is designed to provide information and possible recommendation as to suture material used during closure of the uterus during that procedure. Our intent is to provide data relating to time of uterine closure, blood loss, and post operative pain. These conclusions may provide substantiated recommendations as to self locking and tying suture material in the performance of cesarean section as related to readily available synthetic suture material, which has the need for standard suture knot placement.

Interventions

PROCEDUREStratafix synthetic barbed suture

hysterotomy closure in Cesarian section

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

FEMALE

Age

16 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* Women of childbearing age undergoing primary or repeat cesarean section using regional anesthesia.

Exclusion criteria

* General Anesthesia * Non-consent to participation

Design outcomes

Primary

Measure	Time frame	Description
Blood loss in closure with barbed synthetic suture	2 days	monitoring of preoperative and postoperative hemoglobin and hematcrit

Secondary

Measure	Time frame	Description
Post operative pain after cesarean secton	3 days	using visual analog pain scale, compare standard closure to barbed suture closure pain

Other

Measure	Time frame	Description
time to close uterine hysterotomy incision comparing standard and barbed suture	total time comparision of closure rates over course of study period (2 years)	comparing time to closure hysterotomy incision of standard suture verse barbed suture

Countries

United States

Outcome results

None listed

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