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

Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159871
• Other study ID #: BRZ 0018-16 CTIL
• Status: Completed
• Phase: N/A
• Start date: June 29, 2016
• Est. completion date: December 24, 2017

Study information

• Verified date: May 2018
• Source: Barzilai Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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..

Recruitment information / eligibility

• Status: Completed
• Enrollment: 73
• Est. completion date: December 24, 2017
• Est. primary completion date: December 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Patients with blood clotting disorders.

Related Conditions & MeSH terms

• Cesarean Section

Intervention

Device:
• Stratafix suture
Stratafix barbed sutures during C-Sections.
• Vicryl suture
Standart Vicryl suture during C- Sections.

Locations

Country	Name	City	State
Israel	Barzilai Medical Center	Ashqelon

Sponsors (1)

Lead Sponsor	Collaborator
Barzilai Medical Center

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Giampaolino P, De Rosa N, Tommaselli GA, Santangelo F, Nappi C, Sansone A, Bifulco G. Comparison of bidirectional barbed suture Stratafix and conventional suture with intracorporeal knots in laparoscopic myomectomy by office transvaginal hydrolaparoscopic follow-up: a preliminary report. Eur J Obstet Gynecol Reprod Biol. 2015 Dec;195:146-50. doi: 10.1016/j.ejogrb.2015.10.011. Epub 2015 Oct 24. — View Citation

Greenberg JA, Goldman RH. Barbed suture: a review of the technology and clinical uses in obstetrics and gynecology. Rev Obstet Gynecol. 2013;6(3-4):107-15. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time required for uterine closure.	Time measured in minutes and seconds	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).
Secondary	Blood loss during uterine closure	Intraoperative during uterine closure and by blood work during post-operative hospital stay	Estimated period of time is 4 days.