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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.
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..
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stratafix suture | Experimental |
| |
| Vicryl suture | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stratafix suture | Device | Stratafix barbed sutures during C-Sections. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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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Inclusion Criteria:
• Pregnant patients with an obstetrical indication for delivery by Cesarean section
Exclusion Criteria:
• Patients with blood clotting disorders.
females
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Barzilai Medical Center | Ashkelon | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24920976 | Background | 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. | |
| 26540594 | Background | 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;195:146-150. doi: 10.1016/j.ejogrb.2015.10.011. Epub 2015 Oct 24. |
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| Vicryl suture |
| Device |
Standart Vicryl suture during C- Sections. |
|