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OpenTrials
Completed

NCT Number: NCT02517710

Study to Compare Suture Material in Closure of Uterine Incision in Cesarian Section

Prospective single blinded trial comparing standard synthetic suture material to a synthetic barbed suture in closure of uterine incision, during Cesarean section procedures.

Completed

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Key information

Conditions

Hysterotomy Closure

Age range

16 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Evangelical Community Hospital

Lewisburg, Pennsylvania, 17837, United States

About this study

Cesarean section is one of the most common medical procedures women of child bearing age undergo, in the United States and the world. This trial is designed to provide information and possible recommendation as to suture material used during closure of the uterus during that procedure. Our intent is to provide data relating to time of uterine closure, blood loss, and post operative pain. These conclusions may provide substantiated recommendations as to self locking and tying suture material in the performance of cesarean section as related to readily available synthetic suture material, which has the need for standard suture knot placement.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Women of childbearing age undergoing primary or repeat cesarean section using regional anesthesia.

Exclusion criteria

  • General Anesthesia
  • Non-consent to participation

Treatment and study plan

Stratafix synthetic barbed suture

Procedure

hysterotomy closure in Cesarian section

Primary outcomes

  1. Blood loss in closure with barbed synthetic suture

    Time frame: 2 days

    monitoring of preoperative and postoperative hemoglobin and hematcrit

Secondary outcomes

  1. Post operative pain after cesarean secton

    Time frame: 3 days

    using visual analog pain scale, compare standard closure to barbed suture closure pain

Other outcomes

  1. time to close uterine hysterotomy incision comparing standard and barbed suture

    Time frame: total time comparision of closure rates over course of study period (2 years)

    comparing time to closure hysterotomy incision of standard suture verse barbed suture

Sponsors and collaborators

Lead sponsor

Evangelical Community Hospital, Lewisburg, PA

Other

Collaborators

  • Jennifer L. MacDonald, PA
  • Neil Cooper, MS, MS 4
  • Nickolas Serniak, BS, MS 4
  • Ob/GYN Associates of Evangelical Hospital
  • Russell J.Stankiewicz, MD
  • The Commonwealth Medical College

Registry information

Official study title

Single-blinded Prospective Trial Comparing Quantitive Blood Loss, Operative Time, and Post Operative Pain Using Stratafix Barbed Suture in Cesarian Section to the Use of Traditional Suture Material

Acronym: Stratafix

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 7, 2015
Registry last updated
Aug 10, 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.