Trial Outcomes & Findings for Traxi Panniculus Retractor for Cesarean Delivery (NCT NCT03651076)
NCT ID: NCT03651076
Last Updated: 2026-06-24
Results Overview
time from skin incision to closure during cesarean delivery
Recruitment status
TERMINATED
Study phase
NA
Target enrollment
142 participants
Primary outcome timeframe
during cesarean delivery
Results posted on
2026-06-24
Participant Flow
243 screened and approached
142 randomized
Participant milestones
| Measure |
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)
|
|---|---|---|
|
Overall Study
STARTED
|
71
|
71
|
|
Overall Study
COMPLETED
|
67
|
68
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
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)
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
3
|
Baseline Characteristics
Traxi Panniculus Retractor for Cesarean Delivery
Baseline characteristics by cohort
| Measure |
Traxi Panniculus Retraction Group
n=67 Participants
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
n=68 Participants
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.9 years
n=20 Participants
|
35.0 years
n=20 Participants
|
34.4 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
67 Participants
n=20 Participants
|
68 Participants
n=20 Participants
|
135 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
14 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
23 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
45 Participants
n=20 Participants
|
46 Participants
n=20 Participants
|
91 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
8 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
15 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
29 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
33 Participants
n=20 Participants
|
34 Participants
n=20 Participants
|
67 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=20 Participants
|
19 Participants
n=20 Participants
|
37 Participants
n=40 Participants
|
|
BMI at delivery
|
47.9 kilograms/meters-squared
n=20 Participants
|
50.1 kilograms/meters-squared
n=20 Participants
|
48.9 kilograms/meters-squared
n=40 Participants
|
PRIMARY outcome
Timeframe: during cesarean deliverytime from skin incision to closure during cesarean delivery
Outcome measures
| Measure |
Standard of Care
n=68 Participants
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
|
Traxi Panniculus Retraction Group
n=67 Participants
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
|
|---|---|---|
|
Cesarean Delivery Operative Time
|
70 minutes
Interval 57.0 to 86.0
|
65 minutes
Interval 55.0 to 81.0
|
SECONDARY outcome
Timeframe: Immediately prior to cesarean deliveryPopulation: Subset of participants that had pulmonary function tests completed
measure difference in pulmonary function tests (FVC=forced vital capacity) before and after application of panniculus retraction method, immediately prior to cesarean delivery
Outcome measures
| Measure |
Standard of Care
n=28 Participants
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
|
Traxi Panniculus Retraction Group
n=36 Participants
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
|
|---|---|---|
|
Change in Pulmonary Function (Forced Vital Capacity)
|
-0.14 Liters
Interval -0.47 to 0.13
|
-0.06 Liters
Interval -0.2 to 0.12
|
SECONDARY outcome
Timeframe: Immediately prior to cesarean deliveryPopulation: 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
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
Outcome measures
| Measure |
Standard of Care
n=28 Participants
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
|
Traxi Panniculus Retraction Group
n=35 Participants
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
|
|---|---|---|
|
Change in Pulmonary Function (Forced Expiratory Volume)
|
-0.11 Liters
Interval -0.45 to -0.02
|
-0.03 Liters
Interval -0.2 to 0.1
|
SECONDARY outcome
Timeframe: through study completion, approximately 6 to 8 weeksPopulation: 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
patient-reported outcomes regarding surgery and delivery will be obtained using a survey made by the research team with a four level likert scale
Outcome measures
| Measure |
Standard of Care
n=23 Participants
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
|
Traxi Panniculus Retraction Group
n=40 Participants
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
|
|---|---|---|
|
Patient Satisfaction Assessed by a Questionnaire
Number of participants reporting that they felt "Not at all" embarrassed with retraction method
|
19 Participants
|
34 Participants
|
|
Patient Satisfaction Assessed by a Questionnaire
Number of participants reporting that they felt "Very" secure with retraction method
|
19 Participants
|
32 Participants
|
|
Patient Satisfaction Assessed by a Questionnaire
Number of participants reporting that they felt "Very" confident with retraction method
|
15 Participants
|
28 Participants
|
|
Patient Satisfaction Assessed by a Questionnaire
Number of participants reporting that they felt "Not at all" claustrophobic with retraction method
|
19 Participants
|
31 Participants
|
|
Patient Satisfaction Assessed by a Questionnaire
Number of participants reporting they felt "Not at all" uncomfortable with retraction method
|
14 Participants
|
31 Participants
|
|
Patient Satisfaction Assessed by a Questionnaire
Number of participants reporting that their upper body movement was "Not at all" constrained
|
17 Participants
|
35 Participants
|
|
Patient Satisfaction Assessed by a Questionnaire
Number of participants reporting that it was "Not at all" difficult to breathe with retraction
|
17 Participants
|
33 Participants
|
|
Patient Satisfaction Assessed by a Questionnaire
Number of participants reporting that they felt that staff treated them "Very" respectfully
|
23 Participants
|
38 Participants
|
|
Patient Satisfaction Assessed by a Questionnaire
Number of participants reporting that they "Definitely/Probably" choose this method in the future
|
20 Participants
|
40 Participants
|
SECONDARY outcome
Timeframe: through study completion, approximately 6 to 8 weeksPopulation: 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
provider-reported outcomes regarding surgery will be obtained using survey with an eleven level likert scale
Outcome measures
| Measure |
Standard of Care
n=61 Participants
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
|
Traxi Panniculus Retraction Group
n=62 Participants
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
|
|---|---|---|
|
Provider Satisfaction With a Survey
Number of providers reporting the method of retraction was very effective
|
64 participants
|
163 participants
|
|
Provider Satisfaction With a Survey
Number of providers reporting they were very satisfied with this method
|
50 participants
|
154 participants
|
|
Provider Satisfaction With a Survey
Number of provider survey responses
|
169 participants
|
219 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: during cesarean deliveryestimated blood loss reported on operative report
Outcome measures
| Measure |
Standard of Care
n=68 Participants
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
|
Traxi Panniculus Retraction Group
n=67 Participants
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
|
|---|---|---|
|
Estimated Blood Loss
|
800 mililiters
Interval 700.0 to 1000.0
|
800 mililiters
Interval 700.0 to 1000.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: through study completion, approximately 6 to 8 weeksreview of medical records for 6 weeks postpartum to evaluate for wound opening or infection rates
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: during cesarean delivery (incision to skin closure)recorded number of scrubbed personnel needed to assist with surgery
Outcome measures
| Measure |
Standard of Care
n=68 Participants
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
|
Traxi Panniculus Retraction Group
n=67 Participants
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
|
|---|---|---|
|
Number of Personnel Involved in Cesarean
Three scrubbed personnel
|
40 Participants
|
40 Participants
|
|
Number of Personnel Involved in Cesarean
Four scrubbed personnel
|
27 Participants
|
24 Participants
|
|
Number of Personnel Involved in Cesarean
Five scrubbed personnel
|
1 Participants
|
3 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From immediately postpartum to discharge from hospital, up to 30 daysPopulation: Number of participants included in analysis
Hospital length of stay in days immediately post-delivery
Outcome measures
| Measure |
Standard of Care
n=68 Participants
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
|
Traxi Panniculus Retraction Group
n=67 Participants
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
|
|---|---|---|
|
Hospital Length of Stay Immediately Post-delivery
|
3.7 days
Interval 2.9 to 3.9
|
3.7 days
Interval 2.9 to 4.0
|
OTHER_PRE_SPECIFIED outcome
Timeframe: From delivery to 30 days post-deliveryTotal Number of Infants Admitted to the Neonatal Intensive Care Unit (NICU)
Outcome measures
| Measure |
Standard of Care
n=68 Participants
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
|
Traxi Panniculus Retraction Group
n=67 Participants
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
|
|---|---|---|
|
NICU Admission (Neonatal Outcome)
|
15 Participants
|
16 Participants
|
Adverse Events
Traxi Panniculus Retraction Group
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Standard of Care
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Traxi Panniculus Retraction Group
n=67 participants at risk
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
n=68 participants at risk
Standard methods of panniculus retraction as determined by individual provider (including medical taping, extra personnel for retraction)
|
|---|---|---|
|
Injury, poisoning and procedural complications
Wound disruption
|
9.0%
6/67 • Number of events 6 • 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
|
5.9%
4/68 • Number of events 4 • 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
|
Additional Information
Dr. Ai-ris Y. Collier, Co-Director of Clinical Trials Unit
Beth Israel Deaconess Medical Center
Phone: 617-667-2636
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place