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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04458415
• Other study ID #: 2020-0361
• Status: Withdrawn
• Phase: N/A
• Start date: June 1, 2021
• Est. completion date: April 30, 2022

Study information

• Verified date: August 2021
• Source: Geisinger Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 30, 2022
• Est. primary completion date: January 30, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Use of Alexis or any other retractor
• General anesthesia
• Fetal demise
• Placenta previa
• History of bariatric surgery
• Adhesive allergy

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Traxi Panniculus Retractor (TPR)
Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.
• Silk Tape
Surgeon uses silk tape to retract the panniculus during C-Section.

Locations

Country	Name	City	State
United States	Geisinger Medical Center	Danville	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Geisinger Clinic	Clinical Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time from skin incision to delivery		During surgery-skin incision to delivery
Secondary	Time from hysterotomy to delivery		During surgery-hysterotomy to delivery
Secondary	Time from skin incision to closure of fascia		During surgery-skin incision to closure of fascia
Secondary	Time from skin incision to skin closure		During surgery-skin incision to skin closure