NCT03651076

Traxi Panniculus Retractor for Cesarean Delivery

Randomized Controlled Trial of Panniculus Retraction Methods for Cesarean Delivery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 141 (actual)
• Sponsor: Beth Israel Deaconess Medical Center · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Obesity, Morbid
• Cesarean Section Complications

Interventions

Type	Name	Description
DEVICE	Traxi panniculus retraction (Clinical Innovations, LLC)	class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy

Timeline

• Start date: 2018-10-02
• Primary completion: 2025-02-01
• Completion: 2025-02-01
• First posted: 2018-08-29
• Last updated: 2025-02-10

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study