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Suture

Barbed Suture for Cesarean Section

N/A

Waitlist Available

Led By Luciana Vieira, MD

Research Sponsored by Icahn School of Medicine at Mount Sinai

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1, at delivery and 2 weeks

Awards & highlights

Study Summary

This trial is testing whether using a barbed suture to close the uterine incision during a scheduled cesarean section leads to less blood loss compared to using a standard suture.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1, at delivery and 2 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1, at delivery and 2 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1, at delivery and 2 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Quantitative blood loss

Secondary outcome measures

Change in Pain score

Number of hemostatic sutures

Surgical sutures

+2 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Barbed sutureExperimental Treatment1 Intervention

Barbed suture type is STRATAFIX Symmetric PDS Plus Knotless Tissue

Group II: Standard sutureActive Control1 Intervention

Standard antimicrobial suture (vicryl) - control arm

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Barbed suture

2021

N/A

~230

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Icahn School of Medicine at Mount SinaiLead Sponsor

857 Previous Clinical Trials

524,045 Total Patients Enrolled

Luciana Vieira, MDPrincipal Investigator - Icahn School of Medicine at Mount Sinai Hospital

Icahn School of Medicine at Mount Sinai

Calvin Lambert, MDPrincipal InvestigatorIcahn School of Medicine at Mount Sinai Hospital

Media Library

Barbed suture (Suture) Clinical Trial Eligibility Overview. Trial Name: NCT04622267 — N/A

Cesarean Section Research Study Groups: Barbed suture, Standard suture

Cesarean Section Clinical Trial 2023: Barbed suture Highlights & Side Effects. Trial Name: NCT04622267 — N/A

Barbed suture (Suture) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04622267 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What criteria would make a candidate an ideal participant for this clinical experiment?

"This clinical trial, looking to recruit 226 participants, requires that patients have undergone a hysterotomy and are aged from 18 to 64."

Answered by AI

Does this investigation permit geriatric patients to participate?

"The inclusion criteria of this clinical trial state that the age limit for participants must be 18 years and above, but not exceed 64."

Answered by AI

Does this research program have open enrollment slots?

"Affirmative. Clinicaltrials.gov conveys that this clinical investigation is presently enrolling patients; the trial went live on July 21st 2021, and was last revised on September 9th 2022. This study requires 226 individuals from a single research outpost."

Answered by AI

What is the number of enrollees in this medical research?

"Affirmative. The clinicaltrial.gov registry indicates that the study, which was first published on July 21st 2021, is actively recruiting individuals for participation. Approximately 226 subjects need to be enlisted from a single medical facility."

Answered by AI

Recent research and studies

BMC SurgeryJournal

Differences of Tensile Strength in Knot Tying Technique Between Orthopaedic Surgical Instructors and Trainees

Harato, Kengo, Mitsuru Yagi, Kazuya Kaneda, Yu Iwama, Akihiko Masuda, Yosuke Kaneko, Akihito Oya, et al.. 2021. “Differences of Tensile Strength in Knot Tying Technique Between Orthopaedic Surgical Instructors and Trainees”. BMC Surgery. Springer Science and Business Media LLC. doi:10.1186/s12893-021-01079-5.

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

formation/NLM/NIH, NCBI. “Gprobe”. 2017. Web. <https://github.com/ncbi/gprobe>..Journal

Gprobe

Information/NLM/NIH, NCBI. 2017. “Gprobe”. GitHub repository. https://github.com/ncbi/gprobe.

clinicaltrials.govStudy