Traxi Panniculus Retractor for Cesarean Delivery

NCT03651076 | Terminated FDA Device

• 1 other identifier: 2018P000369
• Study Type: interventional
• Target: 141
• Locations: 1 country
• Sites: 2

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.

Conditions

Obesity, Morbid; Cesarean Section Complications

Outcome Measures

Primary Outcomes (1)

• Cesarean delivery operative time

  time from skin incision to closure during cesarean delivery

  through study completion, approximately 6 to 8 weeks

Secondary Outcomes (4)

• Change in pulmonary function (forced vital capacity)

  through study completion, approximately 6 to 8 weeks

• Change in pulmonary function (forced expiratory volume)

  through study completion, approximately 6 to 8 weeks

• Patient satisfaction assessed by a questionnaire

  through study completion, approximately 6 to 8 weeks

• Provider satisfaction with a survey

  through study completion, approximately 6 to 8 weeks

Other Outcomes (5)

• Estimated blood loss

  through study completion, approximately 6 to 8 weeks

• Wound complication

  through study completion, approximately 6 to 8 weeks

• Number of personnel involved in cesarean

  through study completion, approximately 6 to 8 weeks

Study Arms (2)

Traxi panniculus retraction group

EXPERIMENTAL

The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider.

Device: Traxi panniculus retraction (Clinical Innovations, LLC)

Standard of care

NO INTERVENTION

Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)

Interventions

Traxi panniculus retraction (Clinical Innovations, LLC) DEVICE

class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy

Traxi panniculus retraction group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• Fetal demise
• Disruption of abdominal skin (infection, rash, abrasion, laceration)
• Known adhesive allergy

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• Clinical Innovations, LLC: collaborator
• Brigham and Women's Hospital: collaborator

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Ai-ris Collier, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 18, 2018
• First Posted: August 29, 2018
• Study Start: October 2, 2018
• Primary Completion: February 1, 2025
• Study Completion: February 1, 2025
• Last Updated: February 10, 2025

Record last verified: 2025-02

Locations

US (2)