The Effect of a Self-Retaining Pannus Retractor in Obese Patients Undergoing Cesarean Section (Traxi)

The purpose of this study is to investigate the effects of the Traxi Pannus retractor in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections compared to routine pannus retraction techniques. Patients will be randomized to the use of the Traxi retractor during Cesarean section (treatment group) or the use of traditional pannus retraction techniques (control group). The primary outcome to be followed is surgical site disruption. The investigators will also assess the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, postoperative length of stay, need for hospital readmission or emergency room visits, or other complication rates between the two groups.

Study Overview

• Status: Terminated
• Conditions: Obese Patients Undergoing Cesarean Section
• Intervention / Treatment: Device: Traxi Pannus Retractor

Detailed Description

Surgical site infections (SSI) are an important cause of morbidity following cesarean sections. The rate of surgical site infections following cesarean section in the United States is estimated between 3-15%, depending on the population studied, definitions of surgical site infection used, and length of time studied and is often underestimated. Morbidities include longer length of hospital stay, hospital readmission, wound opening and re-exploration, need for home health care, increased health care costs and loss of productivity. The risk of developing a SSI after a Cesarean section is increased with certain patient characteristics, such as obesity and duration of surgery and is decreased with the use prophylactic antibiotics prior to the skin incision.

Obesity is a significant public health problem and the incidence continues to increase in the United States. It has been shown to be associated with increased risk of SSI after cesarean section in several studies. Olsen et al reviewed 1,605 patients who underwent cesarean section and found increased BMI at admission was an independent risk factor for SSI. In another study of 19,416 women in Israel who had cesarean deliveries, women who had a BMI ≥30 kg/m2 had an increased risk for infection (odds ratio [OR} =2.2; 95% Confidence Interval [CI]. Leth, et al. also found obesity as a risk factor associated with wound infection. In this study of 2,492 consecutive women who had cesarean sections in Denmark, infection rates increased with increasing BMI, with women with a BMI kg/m2 30.0-34.9 having an infection rate of 19.1% and women with a BMI of 35.0-39.9 kg/m2 and of ≥40 kg/m2 both having infection rates of 31.1%. Hypotheses for the increased rate of wound infections in obese patients include decreased vascularity of adipose tissue, increase in wound area, and poorer penetration of prophylactic antibiotics to adipose tissue. Adequate surgical exposure and good visualization are paramount in abdominal surgery. Retraction of the pannus cephalad is often required for adequate visualization and access to the lower abdomen and thus the lower uterine segment. Several studies have been shown that pfannensteil or joel-cohen incisions are superior to vertical incisions due to increased risk of classical cesarean delivery in the case of the obese gravida. Limited studies have been completed to assess supra umbilical incisions.

Other methods of pannus retraction are currently utilized in obstetrics surgery, mostly with surgical tape or Montgomery straps. However, there are currently no clinical trials comparing types of pannus retractors. Potential benefits from the Traxi retractor are decreased operating time, decreased need for additional operating room personnel, and increased ease of delivery of neonate. In addition, the Traxi is designed to stay on for 24 hours in order to elevate the pannus, this will decrease exposure to moisture and possibly other bacteria as the skin begins to heal.

• Study Type: Interventional
• Enrollment (Actual): 4
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 50 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Pregnant women with a BMI greater than or equal to 30 kg/m squared, aged 14-50 years old, undergoing non-emergent cesarean section for delivery and require pannus displacement for surgery.

Physicians Inclusion would include any physician who routinely perform C-sections

Exclusion Criteria:

• Patients undergoing emergency Cesarean-section Pre-existing concurrent infection including chorioamnionitis State of immunosuppression (ie. HIV, cancer) Long-term steroid use (>2 days) Patients with a BMI <30 kg/m2, or those with a BMI >/=30kg who do not require pannus retraction.

If there is a rash in the area of retraction Adhesive/tape allergy. Physicians exclusion would include any physician who does not routinely perform C-sections.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment; Subjects will receive use of the Traxi pannus retractor when undergoing cesarean section	Device: Traxi Pannus Retractor; traxi® Panniculus Retractor is a retraction device used for retraction of the panniculus during surgical procedures. traxi retracts and holds the panniculus for the duration of the operation, freeing the surgeons hands and those of the staff to better care for the patient.
No Intervention: Standard; Patients will receive use of the standard of care option which is the montgomery straps

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Disruption Rates	To determine if there is a difference in wound disruption rates, in obese patients who have Cesarean sections when the Traxi retractor is used during Cesarean sections, when compared to traditional pannus retractor techniques, montogmery straps.	24 hours from placement of device

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of Surgery or Length of Time From Skin Incision to Delivery of the Infant	To determine if there is a difference in duration of surgery or length of time from skin incision to delivery of the infant between the treatment group and the control/standard group.	At time of surgery
Change in Hemoglobin	To determine if there is a difference in change in hemoglobin between the control/standard group and the treatment group.	24 hours after surgery
Estimated Blood Loss	To determine if there is a difference in estimated blood loss between the treatment group and the control/standard group.	At time of surgery
Postoperative Length of Stay	To determine if there is a difference in postoperative length of stay between the treatment group and the control/standard group.	3-4 days
Other Complication Rate	To determine if there is a difference in other complication rates between the treatment group and the control/standard group.	6 weeks
Need for Hospital Readmission or Emergency Room Visits	To determine if there is a difference in need for hospital readmission or emergency room visits between the treatment group and the control/standard group.	6 weeks

Collaborators and Investigators

• Sponsor: St. Louis University

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): January 2, 2017
• Study Completion (Actual): January 2, 2017

Study Registration Dates

• First Submitted: August 4, 2016
• First Submitted That Met QC Criteria: August 9, 2016
• First Posted (Estimate): August 12, 2016

Study Record Updates

• Last Update Posted (Actual): June 4, 2018
• Last Update Submitted That Met QC Criteria: May 2, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: 26533

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No