Viewing Study NCT03041220


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Study NCT ID: NCT03041220
Status: WITHDRAWN
Last Update Posted: 2023-08-14
First Post: 2017-01-11
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Best Incision Site for Obese Patients - Low Versus High Transverse
Sponsor: University of Nebraska
Organization:

Study Overview

Official Title: Best Incision Site for Obese Patients - Low Versus High Transverse
Status: WITHDRAWN
Status Verified Date: 2023-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: PI no longer at institution
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Retrospective chart review using both out patient and inpatient records of obese patients (BMI of 30 or greater) who have had a cesarean section since the year 2009. We will evaluate the patient's BMI, their skin incision type at time of c-section, their co-morbidities, number of previous c-sections and post partum follow up for wound infection, wound separation and wound breakdown. We will also review operative notes to evaluate blood loss, length of surgery and complications during surgery. We will obtain maternal characteristics and information about the pregnancy.
Detailed Description: Past studies have looked primarily at vertical vs low transverse skin incision. There is data that performing a high transverse skin incision on obese patients leads to better visualization and less wound infection but there are few studies comparing it directly to low transverse skin incision.

Retrospective chart review of obese patient's who have had a cesarean section at St Mary's hospital by either a low or high transverse skin incision between January 1, 2009 - July 31, 2014. We will review charts up to 6 week postpartum.

Pregnancies will be identified through identifing those who have cesarean sections. They will be narrowed down by those who have BMI of \> 30. Maternal prenatal records, postnatal records and delivery records will be reviewed.

Study Oversight

Has Oversight DMC: False
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: