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OpenTrials
Completed

NCT Number: NCT03159871

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

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.

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Key information

Conditions

Cesarean Section

Age range

18 year–42 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Barzilai Medical Center

Ashkelon, Israel

About this study

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..

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Patients with blood clotting disorders.

Treatment and study plan

Stratafix suture

Device

Stratafix barbed sutures during C-Sections.

Vicryl suture

Device

Standart Vicryl suture during C- Sections.

Primary outcomes

  1. Time required for uterine closure.

    Time frame: 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 outcomes

  1. Blood loss during uterine closure

    Time frame: Estimated period of time is 4 days.

    Intraoperative during uterine closure and by blood work during post-operative hospital stay

Sponsors and collaborators

Lead sponsor

Barzilai Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
May 19, 2017
Registry last updated
May 31, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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