An interventional study of Traxi panniculus retraction (Clinical Innovations, LLC) in Obesity, Morbid and Cesarean Section Complications, sponsored by Beth Israel Deaconess Medical Center. Terminated at 2 sites in United States. Open to female participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2026-06-24.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Other
This prospective, open-label, randomized-controlled trial is designed to evaluate the use of the Traxi panniculus retractor-- a commercially available Class I FDA-exempt device will improve surgical outcomes, cardiopulmonary function, and provider/patient satisfaction in morbidly obese women undergoing cesarean delivery.
Morbidly obese women (BMI >/= 40) undergoing non-emergent cesarean delivery will be recruited and randomized to Traxi panniculus retraction or standard of care for panniculus retraction.
The primary outcome evaluated will be operating time (incision to closure). Other secondary outcomes related to surgery including estimated blood loss, surgical site infection, and number of scrubbed personnel.
A secondary aim of the study is to evaluate the hypothesis that the Traxi retraction device reduces chestwall compression panniculus retraction and will improve intraoperative pulmonary function. To do this, the investigators will measure the difference in individual participant pulmonary function tests (forced vital capacity, forced expiratory volume) before and after panniculus retraction using a bedside spirometer.
A tertiary aim of the study is to evaluate the hypothesis that the Traxi retraction device will improve patient and provider satisfaction due to improved delivery experience and maintaining patient dignity. Patient and provider-reported outcomes will be evaluated using surveys.
922 studies on the registry are indexed under Obesity, Morbid; 172 are open to participants now.
This study's enrollment of 142 is above the median of 60 across 590 interventional studies indexed under Obesity, Morbid.
Browse Obesity, Morbid studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
Of its 75 completed or terminated interventional studies of FDA-regulated products, 61 (81%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider.
Device: Traxi panniculus retraction (Clinical Innovations, LLC)
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy
Cesarean Delivery Operative Time
time from skin incision to closure during cesarean delivery
Time frame: during cesarean delivery
Change in Pulmonary Function (Forced Vital Capacity)
measure difference in pulmonary function tests (FVC=forced vital capacity) before and after application of panniculus retraction method, immediately prior to cesarean delivery
Time frame: Immediately prior to cesarean delivery
Change in Pulmonary Function (Forced Expiratory Volume)
measure difference in pulmonary function tests (FEV1=forced expiratory volume in 1 minute) before and after application of panniculus retraction method, immediately prior to cesarean delivery
Time frame: Immediately prior to cesarean delivery
Patient Satisfaction Assessed by a Questionnaire
patient-reported outcomes regarding surgery and delivery will be obtained using a survey made by the research team with a four level likert scale
Time frame: through study completion, approximately 6 to 8 weeks
Provider Satisfaction With a Survey
provider-reported outcomes regarding surgery will be obtained using survey with an eleven level likert scale
Time frame: through study completion, approximately 6 to 8 weeks
Estimated Blood Loss
estimated blood loss reported on operative report
Time frame: during cesarean delivery
Wound Complication
review of medical records for 6 weeks postpartum to evaluate for wound opening or infection rates
Time frame: through study completion, approximately 6 to 8 weeks
Number of Personnel Involved in Cesarean
recorded number of scrubbed personnel needed to assist with surgery
Time frame: during cesarean delivery (incision to skin closure)
Hospital Length of Stay Immediately Post-delivery
Hospital length of stay in days immediately post-delivery
Time frame: From immediately postpartum to discharge from hospital, up to 30 days
NICU Admission (Neonatal Outcome)
Total Number of Infants Admitted to the Neonatal Intensive Care Unit (NICU)
Time frame: From delivery to 30 days post-delivery
243 screened and approached
| Milestone | Traxi Panniculus Retraction Group | Standard of Care |
|---|---|---|
| Started | 71 | 71 |
| Completed | 67 | 68 |
| Not completed | 4 | 3 |
| Withdrew: Lost to follow-up | 4 | 3 |
time from skin incision to closure during cesarean delivery
| minutes | Traxi Panniculus Retraction Group | Standard of Care |
|---|---|---|
| Cesarean Delivery Operative Time | 65 (55 to 81) | 70 (57 to 86) |
measure difference in pulmonary function tests (FVC=forced vital capacity) before and after application of panniculus retraction method, immediately prior to cesarean delivery
| Liters | Traxi Panniculus Retraction Group | Standard of Care |
|---|---|---|
| Change in Pulmonary Function (Forced Vital Capacity) | -0.06 (-0.20 to 0.12) | -0.14 (-0.47 to 0.13) |
measure difference in pulmonary function tests (FEV1=forced expiratory volume in 1 minute) before and after application of panniculus retraction method, immediately prior to cesarean delivery
| Liters | Traxi Panniculus Retraction Group | Standard of Care |
|---|---|---|
| Change in Pulmonary Function (Forced Expiratory Volume) | -0.03 (-0.20 to 0.10) | -0.11 (-0.45 to -0.02) |
patient-reported outcomes regarding surgery and delivery will be obtained using a survey made by the research team with a four level likert scale
| Participants | Traxi Panniculus Retraction Group | Standard of Care |
|---|---|---|
| Number of participants reporting that they felt "Not at all" embarrassed with retraction method | 34 | 19 |
| Number of participants reporting that they felt "Very" secure with retraction method | 32 | 19 |
| Number of participants reporting that they felt "Very" confident with retraction method | 28 | 15 |
| Number of participants reporting that they felt "Not at all" claustrophobic with retraction method | 31 | 19 |
| Number of participants reporting they felt "Not at all" uncomfortable with retraction method | 31 | 14 |
| Number of participants reporting that their upper body movement was "Not at all" constrained | 35 | 17 |
| Number of participants reporting that it was "Not at all" difficult to breathe with retraction | 33 | 17 |
| Number of participants reporting that they felt that staff treated them "Very" respectfully | 38 | 23 |
| Number of participants reporting that they "Definitely/Probably" choose this method in the future | 40 | 20 |
provider-reported outcomes regarding surgery will be obtained using survey with an eleven level likert scale
| participants | Traxi Panniculus Retraction Group | Standard of Care |
|---|---|---|
| Number of provider survey responses | 219 | 169 |
| Number of providers reporting the method of retraction was very effective | 163 | 64 |
| Number of providers reporting they were very satisfied with this method | 154 | 50 |
estimated blood loss reported on operative report
| mililiters | Traxi Panniculus Retraction Group | Standard of Care |
|---|---|---|
| Estimated Blood Loss | 800 (700 to 1000) | 800 (700 to 1000) |
review of medical records for 6 weeks postpartum to evaluate for wound opening or infection rates
Results for this outcome have not been posted.
recorded number of scrubbed personnel needed to assist with surgery
| Participants | Traxi Panniculus Retraction Group | Standard of Care |
|---|---|---|
| Three scrubbed personnel | 40 | 40 |
| Four scrubbed personnel | 24 | 27 |
| Five scrubbed personnel | 3 | 1 |
Hospital length of stay in days immediately post-delivery
| days | Traxi Panniculus Retraction Group | Standard of Care |
|---|---|---|
| Hospital Length of Stay Immediately Post-delivery | 3.7 (2.9 to 4) | 3.7 (2.9 to 3.9) |
Total Number of Infants Admitted to the Neonatal Intensive Care Unit (NICU)
| Participants | Traxi Panniculus Retraction Group | Standard of Care |
|---|---|---|
| NICU Admission (Neonatal Outcome) | 16 | 15 |
Collected over Adverse Events were collected from enrollment until 6 weeks postpartum. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Traxi Panniculus Retraction Group | 0/67 (0%) | 0/67 (0%) | 6/67 (9%) |
| Standard of Care | 0/68 (0%) | 0/68 (0%) | 4/68 (5.9%) |
| Event | Traxi Panniculus Retraction Group | Standard of Care |
|---|---|---|
| Wound disruptionInjury, poisoning and procedural complications | 6/67 | 4/68 |
| Age, Continuous(years) | Traxi Panniculus Retraction Group | Standard of Care | Total |
|---|---|---|---|
| Median | 33.9 (30.9 to 37.3) | 35.0 (30.5 to 38.1) | 34.4 (30.8 to 37.8) |
| Sex: Female, Male(Participants) | Traxi Panniculus Retraction Group | Standard of Care | Total |
|---|---|---|---|
| Female | 67 | 68 | 135 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Traxi Panniculus Retraction Group | Standard of Care | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 9 | 23 |
| Not Hispanic or Latino | 45 | 46 | 91 |
| Unknown or Not Reported | 8 | 13 | 21 |
| Race (NIH/OMB)(Participants) | Traxi Panniculus Retraction Group | Standard of Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 15 | 14 | 29 |
| White | 33 | 34 | 67 |
| More than one race | 1 | 0 | 1 |
| Unknown or Not Reported | 18 | 19 | 37 |
| BMI at delivery(kilograms/meters-squared) | Traxi Panniculus Retraction Group | Standard of Care | Total |
|---|---|---|---|
| Median | 47.9 (44.9 to 52.2) | 50.1 (45.4 to 52.8) | 48.9 (45.0 to 52.5) |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes
Supporting information: Study protocol, Icf, Csr, Analytic code
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Beth Israel Deaconess Medical Center