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

• Sponsor: Geisinger Clinic (Other)
• Overall Status: Withdrawn
• CT.gov ID: NCT04458415
• Collaborator: Clinical Innovations (Industry)
• Enrollment: 0
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.9
• Patients Per Site Per Month: 0

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Obesity	Other: Traxi Panniculus Retractor (TPR); Other: Silk Tape	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 0 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Masking Description: No Masking
• Primary Purpose: Supportive Care
• Official Title: The Effect of Traxi Panniculus Retractor on Surgical Time at Non-emergent Cesarean Delivery in Obese Women
• Anticipated Study Start Date: Jun 1, 2021
• Anticipated Primary Completion Date: Jan 30, 2022
• Anticipated Study Completion Date: Apr 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: TPR Arm Surgeon will use the Traxi Panniculus Retractor to retract the panniculus during cesarean section.	Other: Traxi Panniculus Retractor (TPR); Surgeon uses the Traxi Panniculus Retractor (TPR) surgical retraction device to retract the panniculus during C-Section.
Active Comparator: Silk Tape Arm Surgeon will use silk tape to retract the panniculus during cesarean section.	Other: Silk Tape; Surgeon uses silk tape to retract the panniculus during C-Section.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

1. Time from skin incision to delivery [During surgery-skin incision to delivery]

2. Time from hysterotomy to delivery [During surgery-hysterotomy to delivery]

3. Time from skin incision to closure of fascia [During surgery-skin incision to closure of fascia]

4. Time from skin incision to skin closure [During surgery-skin incision to skin closure]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Geisinger Medical Center	Danville	Pennsylvania	United States	17821

Sponsors and Collaborators

• Geisinger Clinic
• Clinical Innovations

Investigators

• Principal Investigator: Michael J Paglia, MD, Geisinger Clinic

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Geisinger Clinic
• ClinicalTrials.gov Identifier: NCT04458415
• Other Study ID Numbers: 2020-0361
• First Posted: Jul 7, 2020
• Last Update Posted: Aug 11, 2021
• Last Verified: Aug 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Aug 11, 2021