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Traxi Panniculus Retractor for Cesarean Delivery

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ClinicalTrials.gov Identifier: NCT03651076
Recruitment Status : Recruiting
First Posted : August 29, 2018
Last Update Posted : August 23, 2021
Sponsor:
Collaborator:
Clinical Innovations, LLC
Information provided by (Responsible Party):
Ai-ris Collier, Beth Israel Deaconess Medical Center

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.

Condition or disease Intervention/treatment Phase
Obesity, Morbid Cesarean Section Complications Device: Traxi panniculus retraction (Clinical Innovations, LLC) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Randomized Controlled Trial of Panniculus Retraction Methods for Cesarean Delivery
Actual Study Start Date : October 2, 2018
Estimated Primary Completion Date : September 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Cesarean Section

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)



Primary Outcome Measures :
  1. Cesarean delivery operative time [ Time Frame: through study completion, approximately 6 to 8 weeks ]
    time from skin incision to closure during cesarean delivery


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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


Other Outcome Measures:
  1. Estimated blood loss [ Time Frame: through study completion, approximately 6 to 8 weeks ]
    estimated blood loss reported on operative report

  2. Wound complication [ Time Frame: through study completion, approximately 6 to 8 weeks ]
    review of medical records for 6 weeks postpartum to evaluate for wound opening or infection rates

  3. Number of personnel involved in cesarean [ Time Frame: through study completion, approximately 6 to 8 weeks ]
    recorded number of scrubbed personnel needed to assist with surgery

  4. Hospital length of stay [ Time Frame: through study completion, approximately 6 to 8 weeks ]
    inpatient length of stay post-delivery

  5. Composite neonatal outcome [ Time Frame: through study completion, approximately 6 to 8 weeks ]
    composite rate of neonatal intensive care unit (NICU) admission, 5-minute Apgar score <7)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03651076


Contacts
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Contact: Ai-ris Y Collier, MD 6176671726 acollier@bidmc.harvard.edu
Contact: Ricardo Aguayo 6176670837 raguayo@bidmc.harvard.edu

Locations
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United States, Massachusetts
Beth Israel Deaconess Medical Center Recruiting
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Beth Israel Deaconess Medical Center
Clinical Innovations, LLC
Investigators
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Principal Investigator: Ai-ris Collier, MD Beth Israel Deaconess Medical Center
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Responsible Party: Ai-ris Collier, Principal Investigator, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier: NCT03651076    
Other Study ID Numbers: 2018P000369
First Posted: August 29, 2018    Key Record Dates
Last Update Posted: August 23, 2021
Last Verified: August 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Obesity, Morbid
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight