Cesarean Section Complications, Obesity, Morbid
Conditions
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.
Interventions
DEVICETraxi panniculus retraction (Clinical Innovations, LLC)
class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy
Sponsors
Beth Israel Deaconess Medical Center
Clinical Innovations, LLC
Brigham and Women's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cesarean Delivery Operative Time | during cesarean delivery | time from skin incision to closure during cesarean delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Pulmonary Function (Forced Vital Capacity) | Immediately prior to cesarean delivery | measure difference in pulmonary function tests (FVC=forced vital capacity) before and after application of panniculus retraction method, immediately prior to cesarean delivery |
| Change in Pulmonary Function (Forced Expiratory Volume) | Immediately prior to cesarean delivery | 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 |
| Patient Satisfaction Assessed by a Questionnaire | through study completion, approximately 6 to 8 weeks | patient-reported outcomes regarding surgery and delivery will be obtained using a survey made by the research team with a four level likert scale |
| Provider Satisfaction With a Survey | through study completion, approximately 6 to 8 weeks | provider-reported outcomes regarding surgery will be obtained using survey with an eleven level likert scale |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORAi-ris Y Collier, MD
Beth Israel Deaconess Medical Center
Participant flow
Recruitment details
243 screened and approached
Pre-assignment details
142 randomized
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 34.4 years |
| BMI at delivery | 47.9 kilograms/meters-squared |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 46 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 13 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 15 Participants |
| Race (NIH/OMB) More than one race | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 19 Participants |
| Race (NIH/OMB) White | 67 Participants |
| Sex: Female, Male Female | 68 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 67 | 0 / 68 |
| other Total, other adverse events | 6 / 67 | 4 / 68 |
| serious Total, serious adverse events | 0 / 67 | 0 / 68 |
Outcome results
None listed