Traxi Panniculus Retractor for Cesarean Delivery

Obesity, Morbid Clinical Trial

Official title:

Randomized Controlled Trial of Panniculus Retraction Methods for Cesarean Delivery

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03651076
• Other study ID #: 2018P000369
• Status: Recruiting
• Phase: N/A
• Start date: October 2, 2018
• Est. completion date: May 2025

Study information

• Verified date: January 2024
• Source: Beth Israel Deaconess Medical Center
• Contact: Ai-ris Y Collier, MD
• Phone: 6176671726
• Email: acollier[@]bidmc.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: May 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Cesarean Section Complications
• Obesity, Morbid

Intervention

Device:
• Traxi panniculus retraction (Clinical Innovations, LLC)
class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Beth Israel Deaconess Medical Center	Brigham and Women's Hospital, Clinical Innovations, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Estimated blood loss	estimated blood loss reported on operative report	through study completion, approximately 6 to 8 weeks
Other	Wound complication	review of medical records for 6 weeks postpartum to evaluate for wound opening or infection rates	through study completion, approximately 6 to 8 weeks
Other	Number of personnel involved in cesarean	recorded number of scrubbed personnel needed to assist with surgery	through study completion, approximately 6 to 8 weeks
Other	Hospital length of stay	inpatient length of stay post-delivery	through study completion, approximately 6 to 8 weeks
Other	Composite neonatal outcome	composite rate of neonatal intensive care unit (NICU) admission, 5-minute Apgar score <7)	through study completion, approximately 6 to 8 weeks
Primary	Cesarean delivery operative time	time from skin incision to closure during cesarean delivery	through study completion, approximately 6 to 8 weeks
Secondary	Change in pulmonary function (forced vital capacity)	measure difference in pulmonary function tests (FVC=forced vital capacity) before and after application of panniculus retraction method	through study completion, approximately 6 to 8 weeks
Secondary	Change in pulmonary function (forced expiratory volume)	measure difference in pulmonary function tests (FEV1=forced expiratory volume in 1 minute) before and after application of panniculus retraction method	through study completion, approximately 6 to 8 weeks
Secondary	Patient satisfaction assessed by a questionnaire	patient-reported outcomes regarding surgery and delivery will be obtained using a survey made by the research team with a four level likert scale	through study completion, approximately 6 to 8 weeks
Secondary	Provider satisfaction with a survey	provider-reported outcomes regarding surgery will be obtained using survey with an eleven level likert scale	through study completion, approximately 6 to 8 weeks