74: Alexis O-ring wound retractor for the prevention of post-cesarean surgical site infections: a randomized controlled trial

ObjectivePost cesarean surgical site infection (SSI) is a leading, costly cause of maternal morbidity. Specialized retractors that cover the sides of the abdominal incision, such as the Alexis retractor, have been used during clean-contaminated gastrointestinal surgery in order to decrease SSI. There is little data about use of such retractors in obstetrics. The objective of our study was to determine whether the Alexis retractor reduces the risk of SSI in women undergoing cesarean delivery at term.Study DesignWomen undergoing non-emergent cesarean delivery via planned Pfannenstiel incision were randomized to Alexis retractor versus routine retraction. Exclusion criteria included emergent delivery, planned vertical incision, active skin infection, and chorioamnionitis. Our primary outcome was occurrence of SSI. Our secondary outcomes included time to uterine incision, exteriorization of uterus, total operating time, total blood loss, staple skin closure, and post-operative pain. The Alexis retractor was inserted after entry into the abdomen and before the bladder flap was incised. It was removed just before the fascial closure. Statistical analysis was performed using student t and chi-squared tests as appropriate (significance: P < 0.05).ResultsA total of 536 patients were randomized (268 for each group). There were no significant differences in gestational age at delivery, pre-pregnancy BMI, race, or maternal age. There were no differences in time to delivery, total operative time, estimated blood loss, or post-operative pain (see table). There were 7 (2.7%) wound infections in the Alexis arm versus 3 (1.1%) in the routine arm (P=0.20). There was a lower need to exteriorize the uterus in the Alexis group (61.3% vs 91.2%, P<0.0001).ConclusionThere is no significant difference in SSI with the use of the Alexis in women undergoing cesarean delivery at term. The lower need to exteriorize the uterus may have some advantages which we were not powered to detect.Values are expressed in either mean +/- standard deviation or n=number (% of total) ObjectivePost cesarean surgical site infection (SSI) is a leading, costly cause of maternal morbidity. Specialized retractors that cover the sides of the abdominal incision, such as the Alexis retractor, have been used during clean-contaminated gastrointestinal surgery in order to decrease SSI. There is little data about use of such retractors in obstetrics. The objective of our study was to determine whether the Alexis retractor reduces the risk of SSI in women undergoing cesarean delivery at term. Post cesarean surgical site infection (SSI) is a leading, costly cause of maternal morbidity. Specialized retractors that cover the sides of the abdominal incision, such as the Alexis retractor, have been used during clean-contaminated gastrointestinal surgery in order to decrease SSI. There is little data about use of such retractors in obstetrics. The objective of our study was to determine whether the Alexis retractor reduces the risk of SSI in women undergoing cesarean delivery at term. Study DesignWomen undergoing non-emergent cesarean delivery via planned Pfannenstiel incision were randomized to Alexis retractor versus routine retraction. Exclusion criteria included emergent delivery, planned vertical incision, active skin infection, and chorioamnionitis. Our primary outcome was occurrence of SSI. Our secondary outcomes included time to uterine incision, exteriorization of uterus, total operating time, total blood loss, staple skin closure, and post-operative pain. The Alexis retractor was inserted after entry into the abdomen and before the bladder flap was incised. It was removed just before the fascial closure. Statistical analysis was performed using student t and chi-squared tests as appropriate (significance: P < 0.05). Women undergoing non-emergent cesarean delivery via planned Pfannenstiel incision were randomized to Alexis retractor versus routine retraction. Exclusion criteria included emergent delivery, planned vertical incision, active skin infection, and chorioamnionitis. Our primary outcome was occurrence of SSI. Our secondary outcomes included time to uterine incision, exteriorization of uterus, total operating time, total blood loss, staple skin closure, and post-operative pain. The Alexis retractor was inserted after entry into the abdomen and before the bladder flap was incised. It was removed just before the fascial closure. Statistical analysis was performed using student t and chi-squared tests as appropriate (significance: P < 0.05). ResultsA total of 536 patients were randomized (268 for each group). There were no significant differences in gestational age at delivery, pre-pregnancy BMI, race, or maternal age. There were no differences in time to delivery, total operative time, estimated blood loss, or post-operative pain (see table). There were 7 (2.7%) wound infections in the Alexis arm versus 3 (1.1%) in the routine arm (P=0.20). There was a lower need to exteriorize the uterus in the Alexis group (61.3% vs 91.2%, P<0.0001). A total of 536 patients were randomized (268 for each group). There were no significant differences in gestational age at delivery, pre-pregnancy BMI, race, or maternal age. There were no differences in time to delivery, total operative time, estimated blood loss, or post-operative pain (see table). There were 7 (2.7%) wound infections in the Alexis arm versus 3 (1.1%) in the routine arm (P=0.20). There was a lower need to exteriorize the uterus in the Alexis group (61.3% vs 91.2%, P<0.0001). ConclusionThere is no significant difference in SSI with the use of the Alexis in women undergoing cesarean delivery at term. The lower need to exteriorize the uterus may have some advantages which we were not powered to detect.Values are expressed in either mean +/- standard deviation or n=number (% of total) There is no significant difference in SSI with the use of the Alexis in women undergoing cesarean delivery at term. The lower need to exteriorize the uterus may have some advantages which we were not powered to detect.