Self-Retaining Retractor in Obese Patients Undergoing Cesarean Section

NCT01826604 | Completed Results DMC

• 1 other identifier: 22591
• Study Type: interventional
• Target: 301
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to investigate the effects of the Alexis O C-section retractor in obese patients (BMI ≥30 kg/m2) who undergo Cesarean sections. Patients will be randomized to the use of the Alexis retractor during Cesarean section (treatment group) or the use of traditional hand-held retractors (control group). We will determine if there is any difference in surgical site infection or wound disruption rates. We will also determine if there is a difference in the duration of surgery or length of time from skin incision to delivery of the infant, change in hemoglobin, estimated blood loss, and postoperative length of stay, intra-operative or postoperative anti-emetic requirements, need for hospital readmission or emergency room visits, or other complication rate between the two groups.

Conditions

Pregnancy; Obese

Keywords

cesarean section; Pregnant

Outcome Measures

Primary Outcomes (1)

• Wound Infection or Disruption

  We will compare the number of patients with wound infections or disruptions when the Alexis O C-Section retractor is used vs when it is not used.

  Time of surgery to 30 days post op

Secondary Outcomes (1)

• Secondary Outcomes Will Include the Differences Between the Two Groups.

  From the time of surgery to 30 days post-op.

Study Arms (2)

Alexis O C-section retractor

EXPERIMENTAL

Alexis O C-section retractor will be used.

Device: Alexis O C-Section Retractor

Control- Conventional retractors

OTHER

Conventional retractors for C-sections will be used.

Other: Control- Conventional retractors

Interventions

Alexis O C-Section Retractor DEVICE

The Alexis O C-section retractor will be used.

Also known as: C-section dual ring retractor, Self retaining barrier retractor

Alexis O C-section retractor

Control- Conventional retractors OTHER

Conventional hand-held retractors will be used. A self-retaining barrier retractor will not be used.

Also known as: Doyen retractor, Bladder blade, Richardson retractor

Control- Conventional retractors

Eligibility Criteria

• Age: 14 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Pregnant women
• BMI greater than or equal to 30 kg/m squared
• Aged 14-50 years old
• Undergoing non-emergent cesarean section for delivery

You may not qualify if:

• Subjects undergoing emergency Cesarean-section
• Pre-existing concurrent infection other than chorioamnionitis
• State of immunosuppression (ie. HIV, cancer)
• Long-term steroid use (\>2 days)
• Subjects with a BMI \<30 kg/m2

Sponsors & Collaborators

• St. Louis University: lead

Study Sites (1)

St. Mary's Health Center

St Louis, Missouri, 63117, United States

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. Katherine M. Scolari Childress
• Organization: Saint Louis University

scolarik@slu.edu

314-977-2090

Study Officials

• Katherine Scolari Childress, M.D.

  St. Louis University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 1, 2013
• First Posted: April 8, 2013
• Study Start: January 1, 2013
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: October 3, 2016
• Results First Posted: October 3, 2016

Record last verified: 2016-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)