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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03159871
Other study ID # BRZ 0018-16 CTIL
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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.
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