Clinical trial NCT03651076: Traxi Panniculus Retractor for Cesarean Delivery
Official title: Randomized Controlled Trial of Panniculus Retraction Methods for Cesarean Delivery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity, Morbid
Cesarean Section Complications
Lead sponsor: Beth Israel Deaconess Medical Center
Sponsor class: OTHER
Collaborators: name: Clinical Innovations, LLC
name: Brigham and Women's Hospital
First posted: 2018-08-29
Enrollment: 141
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Cesarean delivery operative time
timeFrame: through study completion, approximately 6 to 8 weeks
Secondary outcomes:
measure: Change in pulmonary function (forced vital capacity)
timeFrame: through study completion, approximately 6 to 8 weeks
measure: Change in pulmonary function (forced expiratory volume)
timeFrame: through study completion, approximately 6 to 8 weeks
measure: Patient satisfaction assessed by a questionnaire
timeFrame: through study completion, approximately 6 to 8 weeks
measure: Provider satisfaction with a survey
timeFrame: through study completion, approximately 6 to 8 weeks
Other outcomes:
measure: Estimated blood loss
timeFrame: through study completion, approximately 6 to 8 weeks
measure: Wound complication
timeFrame: through study completion, approximately 6 to 8 weeks
measure: Number of personnel involved in cesarean
timeFrame: through study completion, approximately 6 to 8 weeks
measure: Hospital length of stay
timeFrame: through study completion, approximately 6 to 8 weeks
measure: Composite neonatal outcome
timeFrame: through study completion, approximately 6 to 8 weeks
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Beth Israel Deaconess Medical Center
state: Massachusetts
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Ai-ris Collier, MD
role: PRINCIPAL_INVESTIGATOR
References: