Trial Outcomes & Findings for Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section (NCT NCT01826604)
NCT ID: NCT01826604
Last Updated: 2016-10-03
Results Overview
We will compare the number of patients with wound infections or disruptions when the Alexis O C-Section retractor is used vs when it is not used.
COMPLETED
NA
301 participants
Time of surgery to 30 days post op
2016-10-03
Participant Flow
This was a randomized controlled trial of obese women (BMI ≥30 kg/m2) undergoing non-emergent Cesarean section at St. Mary's Health Center, March 2013 to September 2014. Patients were randomized to the treatment group (using the Alexis O C-section retractor) or to the control group (using conventional hand-held retractors).
Non-emergent Cesarean delivery was defined by our institution's Cesarean section acuity scale, included those in which there was no immediate threat to the life of the patient or fetus. Not all Cesarean deliveries were elective, patients were included if there was typical time for routine Cesarean section preparation.
Participant milestones
| Measure |
Alexis O C-section Retractor
The Alexis O C-section retractor will be used. Other hand-held retractors will be used as deemed necessary by the surgeon.
Alexis O C-Section Retractor: The Alexis O C-section retractor will be used. Other hand-held retractors that are deemed necessary to the surgery by the physician will also be used.
|
Control
Conventional hand-held surgical retractors used for C-sections will be used, including the bladder blade (Doyen retractor) and the Richardson retractor.
Control- Conventional hand-held retractors: Conventional hand-held retractors will be used. A self-retaining barrier retractor will not be used.
|
|---|---|---|
|
Overall Study
STARTED
|
144
|
157
|
|
Overall Study
COMPLETED
|
136
|
148
|
|
Overall Study
NOT COMPLETED
|
8
|
9
|
Reasons for withdrawal
| Measure |
Alexis O C-section Retractor
The Alexis O C-section retractor will be used. Other hand-held retractors will be used as deemed necessary by the surgeon.
Alexis O C-Section Retractor: The Alexis O C-section retractor will be used. Other hand-held retractors that are deemed necessary to the surgery by the physician will also be used.
|
Control
Conventional hand-held surgical retractors used for C-sections will be used, including the bladder blade (Doyen retractor) and the Richardson retractor.
Control- Conventional hand-held retractors: Conventional hand-held retractors will be used. A self-retaining barrier retractor will not be used.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
8
|
9
|
Baseline Characteristics
Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section
Baseline characteristics by cohort
| Measure |
Alexis O C-section Retractor
n=144 Participants
Alexis O retractor used during C-section
|
Control
n=157 Participants
Other retractor used during C-section
|
Total
n=301 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
144 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
28.5 years
n=5 Participants
|
29 years
n=7 Participants
|
28.8 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
144 Participants
n=5 Participants
|
157 Participants
n=7 Participants
|
301 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
144 participants
n=5 Participants
|
157 participants
n=7 Participants
|
301 participants
n=5 Participants
|
|
Gravidity
|
3 live births
n=5 Participants
|
3 live births
n=7 Participants
|
3 live births
n=5 Participants
|
|
BMI
|
39.9 kg/m2
n=5 Participants
|
40.6 kg/m2
n=7 Participants
|
40.1 kg/m2
n=5 Participants
|
|
Subcutaneous thickness
|
3.0 cm
n=5 Participants
|
3.0 cm
n=7 Participants
|
3.0 cm
n=5 Participants
|
|
Chorioamnionitis
|
8 participants
n=5 Participants
|
6 participants
n=7 Participants
|
14 participants
n=5 Participants
|
|
Group beta streptococcus colonization
|
38 participants
n=5 Participants
|
49 participants
n=7 Participants
|
87 participants
n=5 Participants
|
|
Low transverse-skin incision
|
130 participants
n=5 Participants
|
144 participants
n=7 Participants
|
274 participants
n=5 Participants
|
|
Low transverse-Uterine incision
|
135 participants
n=5 Participants
|
144 participants
n=7 Participants
|
279 participants
n=5 Participants
|
|
Tobacco Use
|
27 participants
n=5 Participants
|
46 participants
n=7 Participants
|
73 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Time of surgery to 30 days post opPopulation: Any SSI or wound disruption during 30 day postoperative period
We will compare the number of patients with wound infections or disruptions when the Alexis O C-Section retractor is used vs when it is not used.
Outcome measures
| Measure |
Alexis Retractor
n=136 Participants
Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
|
Control
n=148 Participants
Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
|
|---|---|---|
|
Wound Infection or Disruption
|
38 participants
|
37 participants
|
SECONDARY outcome
Timeframe: From the time of surgery to 30 days post-op.Population: infection during 30 day postoperative period
Secondary outcomes will include 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 rates between the two groups.
Outcome measures
| Measure |
Alexis Retractor
n=28 Participants
Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
|
Control
n=26 Participants
Outcomes at each time period are additive so that patients who experienced the outcome at each time point are included in the next time point. Patients may have experienced more than one type of outcome and are reported for each outcome experienced. The outcome of SSI or wound disruption includes cumulative of all patients who experienced either type of outcome.
|
|---|---|---|
|
Secondary Outcomes Will Include the Differences Between the Two Groups.
Superficial incisional during 30 day postop
|
14 participants
|
13 participants
|
|
Secondary Outcomes Will Include the Differences Between the Two Groups.
Deep organ/space during 30 day postop
|
6 participants
|
6 participants
|
|
Secondary Outcomes Will Include the Differences Between the Two Groups.
Wound disruption during 30 day postop
|
18 participants
|
18 participants
|
|
Secondary Outcomes Will Include the Differences Between the Two Groups.
Surgical site infection during 30 day postop
|
20 participants
|
19 participants
|
Adverse Events
Alexis Retractor
Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Katherine M. Scolari Childress
Saint Louis University
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place