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Slow accrual due to provider preference
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| Name | Class |
|---|---|
| Clinical Innovations, LLC | INDUSTRY |
| Brigham and Women's Hospital | OTHER |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Traxi panniculus retraction group | Experimental | The method of panniculus retraction will be the Traxi panniculus retraction (Clinical Innovations, LLC) by the provider. |
|
| Standard of care | No Intervention | Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Traxi panniculus retraction (Clinical Innovations, LLC) | Device | class I, FDA-exempt, commercially available for use in panniculus retraction during cesarean delivery or other laparotomy |
| Measure | Description | Time Frame |
|---|---|---|
| Cesarean Delivery Operative Time | time from skin incision to closure during cesarean delivery | during cesarean delivery |
| Measure | Description | Time Frame |
|---|---|---|
| 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, immediately prior to cesarean delivery | Immediately prior to cesarean delivery |
| Change in Pulmonary Function (Forced Expiratory Volume) |
| Measure | Description | Time Frame |
|---|---|---|
| Estimated Blood Loss | estimated blood loss reported on operative report | during cesarean delivery |
| Wound Complication | review of medical records for 6 weeks postpartum to evaluate for wound opening or infection rates |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ai-ris Y Collier, MD | Beth Israel Deaconess Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Brigham and Women's Hospital | Boston | Massachusetts | 02115 | United States | ||
| Beth Israel Deaconess Medical Center |
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After contact with PI and the appropriate local regulatory approvals and contracts in place
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142 randomized
243 screened and approached
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Standard of Care | Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction) |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Cesarean Delivery Operative Time | time from skin incision to closure during cesarean delivery | Posted | Median | Inter-Quartile Range | minutes | during cesarean delivery |
|
Adverse Events were collected from enrollment until 6 weeks postpartum
We collected and reported serious and non-serious adverse events from enrollment until 6 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Wound disruption | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Ai-ris Y. Collier, Co-Director of Clinical Trials Unit | Beth Israel Deaconess Medical Center | 617-667-2636 | acollier@bidmc.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Nov 9, 2023 | Dec 19, 2023 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D009767 | Obesity, Morbid |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
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measure difference in pulmonary function tests (FEV1=forced expiratory volume in 1 minute) before and after application of panniculus retraction method, immediately prior to cesarean delivery |
| Immediately prior to cesarean delivery |
| 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 |
| 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 |
| through study completion, approximately 6 to 8 weeks |
| Number of Personnel Involved in Cesarean | recorded number of scrubbed personnel needed to assist with surgery | during cesarean delivery (incision to skin closure) |
| Hospital Length of Stay Immediately Post-delivery | Hospital length of stay in days immediately post-delivery | From immediately postpartum to discharge from hospital, up to 30 days |
| NICU Admission (Neonatal Outcome) | Total Number of Infants Admitted to the Neonatal Intensive Care Unit (NICU) | From delivery to 30 days post-delivery |
| Boston |
| Massachusetts |
| 02215 |
| United States |
| BG001 |
| Standard of Care |
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction) |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI at delivery | Median | Inter-Quartile Range | kilograms/meters-squared |
|
|
|
| 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, immediately prior to cesarean delivery | Subset of participants that had pulmonary function tests completed | Posted | Median | Inter-Quartile Range | Liters | Immediately prior to cesarean delivery |
|
|
|
| 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, immediately prior to cesarean delivery | Pulmonary function testing was performed only when a trained operator was available. Due to operator availability, not all participants completed the pulmonary function tests. Results were not available for all enrolled participants | Posted | Median | Inter-Quartile Range | Liters | Immediately prior to cesarean delivery |
|
|
|
| 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 | All participants were asked to fill out a patient-reported survey either electronically or on paper; however, not all participants completed the survey. Responses were not available for all enrolled participants | Posted | Count of Participants | Participants | 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 | Number of participants with 1 or more post-operative provider survey responses. All providers (more than one per cesarean delivery) were asked to fill out a provider-reported survey electronically. Each participant could have had more than one provider survey response since there were typically 3 or more personnel involved in the surgery | Posted | Number | participants | through study completion, approximately 6 to 8 weeks |
|
|
|
| Other Pre-specified | Estimated Blood Loss | estimated blood loss reported on operative report | Posted | Median | Inter-Quartile Range | mililiters | during cesarean delivery |
|
|
|
| Other Pre-specified | Wound Complication | review of medical records for 6 weeks postpartum to evaluate for wound opening or infection rates | Not Posted | through study completion, approximately 6 to 8 weeks | Participants |
| Other Pre-specified | Number of Personnel Involved in Cesarean | recorded number of scrubbed personnel needed to assist with surgery | Posted | Count of Participants | Participants | during cesarean delivery (incision to skin closure) |
|
|
|
| Other Pre-specified | Hospital Length of Stay Immediately Post-delivery | Hospital length of stay in days immediately post-delivery | Number of participants included in analysis | Posted | Median | Inter-Quartile Range | days | From immediately postpartum to discharge from hospital, up to 30 days |
|
|
|
| Other Pre-specified | NICU Admission (Neonatal Outcome) | Total Number of Infants Admitted to the Neonatal Intensive Care Unit (NICU) | Posted | Count of Participants | Participants | From delivery to 30 days post-delivery |
|
|
|
| 0 |
| 67 |
| 0 |
| 67 |
| 6 |
| 67 |
| EG001 | Standard of Care | Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction) | 0 | 68 | 0 | 68 | 4 | 68 |
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| D009750 |
| Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Number of participants reporting that they felt "Very" confident with retraction method |
|
| Number of participants reporting that they felt "Not at all" claustrophobic with retraction method |
|
| Number of participants reporting they felt "Not at all" uncomfortable with retraction method |
|
| Number of participants reporting that their upper body movement was "Not at all" constrained |
|
| Number of participants reporting that it was "Not at all" difficult to breathe with retraction |
|
| Number of participants reporting that they felt that staff treated them "Very" respectfully |
|
| Number of participants reporting that they "Definitely/Probably" choose this method in the future |
|
| Number of providers reporting they were very satisfied with this method |
|
| Five scrubbed personnel |
|