Traxi Panniculus Retractor for Cesarean Delivery

Overview

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.

Full Title of Study: “Randomized Controlled Trial of Panniculus Retraction Methods for Cesarean Delivery”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Other
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2025

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

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

Arms, Groups and Cohorts

  • Experimental: Traxi panniculus retraction group
    • The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider.
  • No Intervention: Standard of care
    • Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)

Clinical Trial Outcome Measures

Primary Measures

  • Cesarean delivery operative time
    • Time Frame: through study completion, approximately 6 to 8 weeks
    • time from skin incision to closure during cesarean delivery

Secondary Measures

  • Change in pulmonary function (forced vital capacity)
    • Time Frame: through study completion, approximately 6 to 8 weeks
    • measure difference in pulmonary function tests (FVC=forced vital capacity) before and after application of panniculus retraction method
  • Change in pulmonary function (forced expiratory volume)
    • Time Frame: through study completion, approximately 6 to 8 weeks
    • measure difference in pulmonary function tests (FEV1=forced expiratory volume in 1 minute) before and after application of panniculus retraction method
  • Patient satisfaction assessed by a questionnaire
    • Time Frame: 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
    • Time Frame: through study completion, approximately 6 to 8 weeks
    • provider-reported outcomes regarding surgery will be obtained using survey with an eleven level likert scale

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 50 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Beth Israel Deaconess Medical Center
  • Collaborator
    • Clinical Innovations, LLC
  • Provider of Information About this Clinical Study
    • Principal Investigator: Ai-ris Collier, Principal Investigator – Beth Israel Deaconess Medical Center
  • Overall Official(s)
    • Ai-ris Collier, MD, Principal Investigator, Beth Israel Deaconess Medical Center
  • Overall Contact(s)
    • Ai-ris Y Collier, MD, 6176671726, acollier@bidmc.harvard.edu

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