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

Geisinger Health

Status: Withdrawn

Conditions: Obesity

Treatments: Other: Silk Tape; Other: Traxi Panniculus Retractor (TPR)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04458415

2020-0361

Details and patient eligibility

About

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.

Full 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.

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

TPR Arm

Experimental group

Description:

Surgeon will use the Traxi Panniculus Retractor to retract the panniculus during cesarean section.

Treatment:

Other: Traxi Panniculus Retractor (TPR)

Silk Tape Arm

Active Comparator group

Description:

Surgeon will use silk tape to retract the panniculus during cesarean section.

Treatment:

Other: Silk Tape