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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03651076
Other study ID # 2018P000369
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 2, 2018
Est. completion date May 2025

Study information

Verified date January 2024
Source Beth Israel Deaconess Medical Center
Contact Ai-ris Y Collier, MD
Phone 6176671726
Email acollier@bidmc.harvard.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 240
Est. completion date May 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 50 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Beth Israel Deaconess Medical Center Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts

Sponsors (3)

Lead Sponsor Collaborator
Beth Israel Deaconess Medical Center Brigham and Women's Hospital, Clinical Innovations, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Estimated blood loss estimated blood loss reported on operative report through study completion, approximately 6 to 8 weeks
Other 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
Other Number of personnel involved in cesarean recorded number of scrubbed personnel needed to assist with surgery through study completion, approximately 6 to 8 weeks
Other Hospital length of stay inpatient length of stay post-delivery through study completion, approximately 6 to 8 weeks
Other Composite neonatal outcome composite rate of neonatal intensive care unit (NICU) admission, 5-minute Apgar score <7) through study completion, approximately 6 to 8 weeks
Primary Cesarean delivery operative time time from skin incision to closure during cesarean delivery through study completion, approximately 6 to 8 weeks
Secondary 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 through study completion, approximately 6 to 8 weeks
Secondary 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 through study completion, approximately 6 to 8 weeks
Secondary 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
Secondary 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
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