Clinical Trials Directory

Trials / Withdrawn

WithdrawnNCT04458415

The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women

Status
Withdrawn
Phase
N/A
Study type
Interventional
Enrollment
0 (actual)
Sponsor
Geisinger Clinic · Academic / Other
Sex
Female
Age
Healthy volunteers
Not accepted

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.

Detailed description

The purpose of the study is to assess whether using the Traxi Panniculus Retractor during cesarean section, in obese (BMI greater than or equal to 30kg/m2 at time of delivery) women, can decrease the cesarean operative time compared to using silk tape to retract the panniculus. Operative time is defined as the time from when the patient lies on the operating room table (at completion of the epidural/spinal anesthesia) until fascial closure.

Conditions

Interventions

TypeNameDescription
OTHERTraxi Panniculus Retractor (TPR)Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.
OTHERSilk TapeSurgeon uses silk tape to retract the panniculus during C-Section.

Timeline

Start date
2021-06-01
Primary completion
2022-01-30
Completion
2022-04-30
First posted
2020-07-07
Last updated
2021-08-11

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT04458415. Inclusion in this directory is not an endorsement.