Randomized controlled trial of traxi panniculus retractor use during non‐emergent cesarean delivery

Abstract Objective The objective of our study is to determine whether the use of a self‐retaining panniculus retraction device (traxi) in patients with obesity will improve operative time, pulmonary function, or patient and provider experience for non‐emergent cesarean delivery. Methods Pregnant patients with body mass index (BMI) ≥40 kg/m 2 undergoing non‐emergent cesarean delivery were recruited from two academic hospitals and randomized to traxi panniculus retraction or to no traxi. Computer‐generated block randomization, stratified by prior abdominal surgery, was used to randomize participants in a 1:1 ratio to the traxi or standard care. Demographic information was collected by self‐report. Surgical time from skin incision to closure and clinical data was collected by review of the electronic health record. Pulmonary function testing via spirometer was performed before and after application of retraction. Participant and provider experience was collected postoperatively. Intention‐to‐treat analysis was performed using a Wilcoxon rank‐sum test and a chi‐squared test for continuous and dichotomous variables, respectively. Results We enrolled 135 participants from 2018 to 2024 at two academic hospitals; 67 were randomized to traxi and 68 were randomized to no traxi. Of these, 43 (31.9%) reported no prior abdominal surgery (including prior cesarean or other laparotomy) and the median BMI was 48.9 (interquartile range [IQR] 45.0, 52.5). The trial was terminated before the target sample size of 220 participants was achieved due to slow accrual and waning clinical equipoise. Baseline characteristics of each group were similar. Median surgical time was 65.0 min (IQR 55.0, 81.0) in the traxi group and 70.0 min (IQR 57.0, 86.0) in the no traxi group, but this difference was not statistically significant ( p = 0.31). There was less restrictive pulmonary physiology associated with application of traxi compared to no traxi; the forced expiratory volume in 1 second (FEV1) difference was −0.03 L (−0.20, 0.10) and −0.11 L (−0.45, −0.02) ( p = 0.048), respectively. Providers were significantly more likely to report that the traxi was very effective, not really difficult to use, not really physically uncomfortable to use, very satisfying to use, and a form of retraction that they would very likely recommend to another colleague. All patients in the traxi arm reported they would choose this retraction method in a future cesarean delivery compared to 91% of patients in the no traxi arm; however, this finding was not statistically significant ( p = 0.05). “A little bit” of rash where the method of taping was used within 2 days of surgery was reported by 0% of patients in the traxi arm, compared to the no traxi arm (20%, p = 0.0048). Conclusions Traxi panniculus retraction did not significantly improve surgical time but was associated with less restrictive pulmonary function testing compared with the control arm; these findings should be interpreted in the context of the study's limited sample size. There were higher reports of provider satisfaction with use of traxi compared to the control arm. Patient‐reported satisfaction with use of traxi was high but not statistically different when compared to the control arm with the exception of patient‐reported rash (less in traxi arm).