Traxi Panniculus Retractor for Cesarean Delivery

Beth Israel Lahey Health

Status: Terminated

Conditions: Cesarean Section Complications; Obesity, Morbid

Treatments: Device: Traxi panniculus retraction (Clinical Innovations, LLC)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03651076

2018P000369

Details and patient eligibility

About

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.

Full 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.

Enrollment: 141 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant
• BMI greater than or equal to 40 kg/m^2
• Undergoing non-emergent cesarean delivery
• Able and willing to provide written, informed consent
• Singleton gestation

Exclusion criteria

• Fetal demise
• Disruption of abdominal skin (infection, rash, abrasion, laceration)
• Known adhesive allergy

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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141 participants in 2 patient groups

Traxi panniculus retraction group

Experimental group

Description:

The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider.

Treatment:

Device: Traxi panniculus retraction (Clinical Innovations, LLC)

Standard of care

No Intervention group

Description:

Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)