Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss, Women's Studies |
| Therapuetic Areas: | Endocrinology, Reproductive |
| Healthy: | No |
| Age Range: | 14 - 50 |
| Updated: | 4/21/2016 |
| Start Date: | January 2013 |
| End Date: | September 2014 |
The Effect of a Barrier Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section
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.
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.
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.
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.
Inclusion Criteria:
- Pregnant women
- BMI greater than or equal to 30 kg/m squared
- Aged 14-50 years old
- Undergoing non-emergent cesarean section for delivery
Exclusion Criteria:
- Subjects undergoing emergency Cesarean-section
- Pre-existing concurrent infection other than chorioamnionitis
- State of immunosuppression (ie. HIV, cancer)
- Long-term steroid use (>2 days)
- Subjects with a BMI <30 kg/m2
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