Traxi Panniculus Retractor for Cesarean Delivery
| Status: | Recruiting |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 10/13/2018 |
| Start Date: | October 2, 2018 |
| End Date: | December 2022 |
| Contact: | Ai-ris Y Collier, MD |
| Email: | acollier@bidmc.harvard.edu |
| Phone: | 6176671726 |
Randomized Controlled Trial of Panniculus Retraction Methods for Cesarean Delivery
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.
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.
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.
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
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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