Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section
Condition: Pregnancy; Obese
MeSH terms: Obesity
Study type: Interventional

Summary: 
      The purpose of this study is to investigate the effects of the Alexis O C-section retractor
      in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections. Patients will be randomized
      to the use of the Alexis retractor during Cesarean section (treatment group) or the use of
      traditional hand-held retractors (control group). We will determine if there is any
      difference in surgical site infection or wound disruption rates. We will also determine if
      there is a difference in the duration of surgery or length of time from skin incision to
      delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length
      of stay, intra-operative or postoperative anti-emetic requirements, need for hospital
      readmission or emergency room visits, or other complication rate between the two groups.
    

Detailed description: 
      This study will be a prospective randomized-controlled trial. It will take place at a single
      site at St. Mary's Health Center in Richmond Heights, Missouri. Pregnant women with a BMI ≥
      30 kg/m2 who will be undergoing non-emergent Cesarean sections for delivery will be eligible.
      Exclusion criteria will be patients who are undergoing emergency Cesarean section, patients
      who are in an immunosuppressed state (ie, HIV, cancer), if they have a pre-existing infection
      other than chorioamnionitis at the time of the Cesarean section, or have received steroids
      for more than two days. Chorioamnionitis will be defined by the presence of fever, uterine
      fundal tenderness, maternal tachycardia (>100 beats per minute), fetal tachycardia (>160
      beats per minute), or purulent or foul-smelling vaginal discharge or amniotic fluid [15]. All
      Cesarean sections will be performed for standard indications and not for the purpose of the
      study. After informed consent is obtained in patients who choose to participate, patients
      will be randomly assigned to either the control group (conventional hand-held retractors used
      only) or to the treatment group (Alexis O C-section self-retaining retractor used as well as
      any hand held retractors that are deemed necessary by the surgeon). Both types of retractors
      are commonly used for cesarean sections in obese patients and the choice of retractor is made
      by physician preference. There will be no other differences between the two groups.
      Randomization will occur using a computer-generated randomization process prior to the start
      of the study and the individual assignments will be placed in opaque sealed envelopes. After
      a patient agrees to participate in the study, an envelope will be selected and opened to
      assign the patient to either the treatment or control group.

      The Cesarean section will be performed for standard indications using standard surgical
      practice. All patients will receive pre-operative antibiotics according to St. Mary's Health
      Center standard practice. If the subcutaneous fat layer is >2 cm, it will be closed with a
      suture layer as is accepted standard practice. Both of these measures have been showed to be
      associated with decreased risk of postoperative surgical site infection and are standard
      practice [4, 16]. The depth of the subcutaneous fat layer will be measured during the surgery
      using the sterile ruler that is provided as part of the standard Cesarean section surgical
      instrument tray set. If the patient is assigned to the Alexis retractor group, the Alexis
      retractor will be placed once the peritoneal incision has been made and extended adequately.
      The peritoneal incision is part of the usual surgical technique during Cesarean sections. The
      Alexis retractor will then be placed with the outer ring positioned external to the incision
      overlying the skin, the internal ring positioned inside the peritoneum against the anterior
      abdominal wall, with the connecting clear plastic barrier retracting the abdominal wall. The
      abdominal cavity will be palpated to ensure no abdominal organs have been inadvertently
      incorporated into the retractor as is the accepted protocol when using the Alexis retractor.
      All other aspects of the Cesarean section will be done routinely. Patients will be blinded to
      whether they were in the control or the treatment group. Postoperative care will be the same
      for both groups, according to standard practice. Patients will be followed until 30 days
      postpartum. They will be instructed to follow up for a postoperative incision check 1-2 weeks
      postoperatively. Patients will be contacted by telephone 30 days postoperatively to inquire
      if they have developed any type of surgical site infection in the 30 days postoperatively.
      They will be informed of this process during the consent process. Surgical site infections
      will be defined using the CDC criteria [17]. Information will be collected from the patient's
      hospital and clinic chart, including patient demographic information (patient BMI, maternal
      age, race, gestational age at delivery, number of previous surgeries, gravidity, parity, and
      maternal comorbidities); neonatal outcomes (infant weight, APGAR scores, need for NICU
      admission); indication for cesarean section; if the patient was laboring; the presence or
      absence of ruptured membranes (and length of time if ruptured membranes present); positive or
      negative GBS culture; the presence of chorioamnionitis; type of skin and uterine surgery;
      total duration of surgery and duration from skin incision until delivery of the infant;
      occurrance and type of infection; number of days postoperatively an infection occurred; depth
      of subcutaneous fat layer, estimated blood loss during surgery; change in hemoglobin from
      admission to postoperative Day #1 (a lab for hemoglobin and hematocrit drawn on postoperative
      Day #1 after a Cesarean section is part of routine care); requirement of intra-operative and
      postoperative anti-emetics; type of skin closure performed; length of postoperative hospital
      stay; presence of postoperative infection or wound disruption during hospital admission; the
      need for postoperative antibiotics; and other postoperative complications. Information will
      also be collected from the one to two week postoperative check, including presence of
      infection or wound disruption, need for postoperative antibiotics, need for wound opening or
      exploration, visits to the Emergency Room or need for hospital readmission. Information will
      be collected during the postoperative telephone call that occurs 30 days after the procedure.
      Participants will be asked the same questions which is on the attached question sheet, and
      includes whether the patient experienced a diagnosis of a postoperative infection, need for
      postoperative antibiotics, visit to the Emergency Room or hospital readmission, or other
      complication within 30 days after the Cesarean section.
    

Intervention name(s): Alexis O C-Section Retractor; Control- Conventional retractors
Intervention type(s): Device; Other
Intervention description(s): The Alexis O C-section retractor will be used.; Conventional hand-held retractors will be used. A self-retaining barrier retractor will not be used.
Other intervention name(s): C-section dual ring retractor; Self retaining barrier retractor; Doyen retractor; Bladder blade; Richardson retractor
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Health Services Research
Keywords: cesarean section; Pregnant