Study Stopped
Collaborator discontinued at this site to pursue the study with a different site.
The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women
1 other identifier
interventional
N/A
1 country
1
Brief Summary
This is an unblinded, randomized control trial of obese women to evaluate the impact of the Traxi Panniculus Retractor (TPR) on the cesarean operative time and surgical blood loss when compared to silk tape.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2021
Shorter than P25 for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2020
CompletedFirst Posted
Study publicly available on registry
July 7, 2020
CompletedStudy Start
First participant enrolled
June 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2022
CompletedAugust 11, 2021
August 1, 2021
8 months
June 11, 2020
August 4, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Time from when a subject lies on the OR table to fascial closure
During surgery-Time from when a subject lies on the OR table to fascial closure
Secondary Outcomes (4)
Time from skin incision to delivery
During surgery-skin incision to delivery
Time from hysterotomy to delivery
During surgery-hysterotomy to delivery
Time from skin incision to closure of fascia
During surgery-skin incision to closure of fascia
Time from skin incision to skin closure
During surgery-skin incision to skin closure
Study Arms (2)
TPR Arm
EXPERIMENTALSurgeon will use the Traxi Panniculus Retractor to retract the panniculus during cesarean section.
Silk Tape Arm
ACTIVE COMPARATORSurgeon will use silk tape to retract the panniculus during cesarean section.
Interventions
Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.
Eligibility Criteria
You may qualify if:
- Current BMI equal to or greater than 30 kg/m2 at last prenatal visit or on day of admission to L\&D
- Requires panniculus retractor for cesarean delivery, as determined by the surgeon
- Non-emergent cesarean delivery
- Spinal or epidural anesthesia
- Low transverse skin incision
- Gestational age equal to or more than 32 weeks 0 days
- Singleton pregnancy
- Three or less previous cesarean deliveries.
- English speaking
You may not qualify if:
- Use of Alexis or any other retractor
- General anesthesia
- Fetal demise
- Placenta previa
- History of bariatric surgery
- Adhesive allergy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Geisinger Cliniclead
- Clinical Innovationscollaborator
Study Sites (1)
Geisinger Medical Center
Danville, Pennsylvania, 17821, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael J Paglia, MD
Geisinger Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No Masking
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2020
First Posted
July 7, 2020
Study Start
June 1, 2021
Primary Completion
January 30, 2022
Study Completion
April 30, 2022
Last Updated
August 11, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share