Traxi Panniculus Retractor for Cesarean Delivery

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.

Study Overview

• Status: Terminated
• Conditions: Cesarean Section Complications; Obesity, Morbid
• Intervention / Treatment: Device: Traxi panniculus retraction (Clinical Innovations, LLC)

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.

• Study Type: Interventional
• Enrollment (Actual): 142
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Traxi panniculus retraction group; The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider.	Device: Traxi panniculus retraction (Clinical Innovations, LLC); class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy
No Intervention: Standard of care; Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cesarean Delivery Operative Time	time from skin incision to closure during cesarean delivery	during cesarean delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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, immediately prior to cesarean delivery	Immediately prior to cesarean delivery
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, immediately prior to cesarean delivery	Immediately prior to cesarean delivery
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
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Estimated Blood Loss	estimated blood loss reported on operative report	during cesarean delivery
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
Number of Personnel Involved in Cesarean	recorded number of scrubbed personnel needed to assist with surgery	during cesarean delivery (incision to skin closure)
Hospital Length of Stay Immediately Post-delivery	Hospital length of stay in days immediately post-delivery	From immediately postpartum to discharge from hospital, up to 30 days
NICU Admission (Neonatal Outcome)	Total Number of Infants Admitted to the Neonatal Intensive Care Unit (NICU)	From delivery to 30 days post-delivery

Collaborators and Investigators

• Sponsor: Beth Israel Deaconess Medical Center
• Collaborators: Brigham and Women's Hospital; Clinical Innovations, LLC
• Investigators: Principal Investigator: Ai-ris Y Collier, MD, Beth Israel Deaconess Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 2, 2018
• Primary Completion (Actual): February 1, 2025
• Study Completion (Actual): February 1, 2025

Study Registration Dates

• First Submitted: July 18, 2018
• First Submitted That Met QC Criteria: August 27, 2018
• First Posted (Actual): August 29, 2018

Study Record Updates

• Last Update Posted (Actual): June 24, 2026
• Last Update Submitted That Met QC Criteria: May 28, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nutrition Disorders; Overnutrition; Body Weight; Overweight; Obesity; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Signs and Symptoms; Obesity, Morbid
• Other Study ID Numbers: 2018P000369

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Time Frame: After contact with PI and the appropriate local regulatory approvals and contracts in place
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes