The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women
NCT04458415 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL
Last updated 2021-08-11
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.
Conditions
Interventions
- OTHER
-
Traxi Panniculus Retractor (TPR)
Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.
- OTHER
-
Silk Tape
Surgeon uses silk tape to retract the panniculus during C-Section.
Sponsors & Collaborators
-
Clinical Innovations
collaborator INDUSTRY -
Geisinger Clinic
lead OTHER
Principal Investigators
-
Michael J Paglia, MD · Geisinger Clinic
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2021-06-01
- Primary Completion
- 2022-01-30
- Completion
- 2022-04-30
Countries
- United States
Study Locations
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