Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
141 participants
INTERVENTIONAL
2018-10-02
2025-02-01
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Traxi panniculus retraction group
The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider.
Traxi panniculus retraction (Clinical Innovations, LLC)
class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy
Standard of care
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
No interventions assigned to this group
Interventions
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Traxi panniculus retraction (Clinical Innovations, LLC)
class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy
Eligibility Criteria
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Inclusion Criteria
* 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
* Disruption of abdominal skin (infection, rash, abrasion, laceration)
* Known adhesive allergy
18 Years
50 Years
FEMALE
No
Sponsors
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Clinical Innovations, LLC
INDUSTRY
Brigham and Women's Hospital
OTHER
Beth Israel Deaconess Medical Center
OTHER
Responsible Party
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Ai-ris Collier
Principal Investigator
Principal Investigators
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Ai-ris Collier, MD
Role: PRINCIPAL_INVESTIGATOR
Beth Israel Deaconess Medical Center
Locations
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Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Countries
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Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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2018P000369
Identifier Type: -
Identifier Source: org_study_id
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