Barbed Suture for Hysterotomy Closure During Cesarean Section
Condition: Hysterotomy
Study type: Interventional

Summary: 
      This is a randomized controlled trial. The purpose of this study is to see if patients whose
      uterine incision (hysterotomy), at the time of scheduled cesarean section, is closed with
      barbed suture, have less blood loss compared to women whose incision is closed with the
      standard suture (vicryl). The primary outcome is quantification of blood loss (QBL).
      Secondary outcomes include time for hysterotomy closure, need for additional hemostatic
      sutures, rate of endometritis, use of hemostatic agents, and differences in pain which will
      be assessed by a telephone screening in the days following delivery.

      Study participation will last 1 year and will include the following research procedures :

        1. Randomization to barbed suture vs. standard suture

        2. Collection of data for primary and secondary outcomes

        3. Telephone survey 2 weeks following the procedure to assess pain, bowel/bladder habits,
           and evidence of wound infection. The barbed suture is approved by the FDA for use in
           soft tissue approximation and this is not an off-label usage.
    

Detailed description: 
      This is a prospective, randomized controlled trial (RCT) evaluating whether using a barbed
      suture to close a C-section incision can reduce blood loss. Patients undergoing C-section
      will be randomized with equal allocation to a barbed suture or a standard antimicrobial
      suture. The primary outcome is quantification of blood loss (QBL). Differences between the
      groups will be assessed using a 0.05 level Wilcoxon rank-sum test. Secondary outcomes include
      time for hysterotomy closure, need for additional hemostatic sutures, rate of
      endometritis/SSI (superficial wound infection, deep wound infection, and endometritis) within
      6 weeks postpartum, use of hemostatic agents, and differences in pain which will be assessed
      by a telephone screening in the days following delivery.
    

Intervention name(s): Barbed suture; Standard antimicrobial suture
Intervention type(s): Device; Procedure
Intervention description(s): to close a C-section incision; to close a C-section incision
Other intervention name(s): STRATAFIX Symmetric PDS Plus Knotless Tissue; vicryl
Intervention MeSH terms: Anti-Infective Agents; Anti-Bacterial Agents
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to either the treatment arm or control arm of the study prior to commencement of the cesarean section and following informed consent. Allocation will be concealed to all researchers/providers until this point. The patients will be randomly allocated by block randomization. Generation of random sequence will be done by independent personnel, usually a statistician, who is not going to be involved in the conduct of the RCT. The access to this sequence should be restricted to only a few individuals who absolutely need to have access.
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Barbed suture; Blood loss; Hysterotomy; Cesarean section