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Skin Incisions and Wound Complication Rates for C-sections in Obese Women

Primary Purpose

Obesity, Infection; Cesarean Section, Surgical Wound

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Midline Vertical

High Transverse

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

pre-pregnancy BMI equal or greater than 40

Exclusion Criteria:

prior cesarean section or laparotomy

Sites / Locations

Albany Medical Center Obstetrics and GynecologyRecruiting
Albany Medical Center Obstetrics and GynecologyRecruiting
Albany Medical CenterRecruiting
Albany Medical Center Obstetrics and GynecologyRecruiting
Albany Medical Center Obstetrics and GynecologyRecruiting
Albany Medical Center Obstetrics and GynecologyRecruiting
Albany Medical Center Obstetrics and GynecologyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Arm Label

Low Transverse

Midline Vertical

High Transverse

Arm Description

Patients in this arm will undergo their cesarean section using the standard low transverse skin incision location

Patients in this arm will undergo their cesarean section using a midline vertical skin incision

Patients in this arm will undergo their cesarean section using a high transverse skin incision, above the pannus

Outcomes

Primary Outcome Measures

Wound Complications

Secondary Outcome Measures

Full Information

NCT ID

NCT02685761

First Posted

February 16, 2016

Last Updated

September 12, 2016

Sponsor

Albany Medical College

1. Study Identification

Unique Protocol Identification Number

NCT02685761

Brief Title

Skin Incisions and Wound Complication Rates for C-sections in Obese Women

Official Title

Randomized Controlled Trial of Wound Complication Rates Between Low Transverse, Midline Vertical, and High Transverse Skin Incisions in Women With a BMI of 40 or Above Undergoing a Cesarean Section for Delivery

Study Type

Interventional

2. Study Status

Record Verification Date

September 2016

Overall Recruitment Status

Unknown status

Study Start Date

September 2015 (undefined)

Primary Completion Date

September 2020 (Anticipated)

Study Completion Date

September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Albany Medical College

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

It is the purpose of this study to evaluate the relationship between a low transverse, vertical midline, and supra-panicular high transverse skin incisions and the rate of wound complications in women with a BMI of 40 or greater undergoing a cesarean section for delivery. So far, the choice of incision for the morbidly obese is based only on case reports. No randomized controlled trials have been done up to date comparing these methods. It is our hope that a high transverse incision will have all of the benefits of a low transverse skin incision, with the added benefit of better exposure offered by a vertical midline incision, without the added increased risk of subjecting the woman to a vertical hysterotomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Infection; Cesarean Section, Surgical Wound

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

309 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Low Transverse

Arm Type

No Intervention

Arm Description

Patients in this arm will undergo their cesarean section using the standard low transverse skin incision location

Arm Title

Midline Vertical

Arm Type

Experimental

Arm Description

Patients in this arm will undergo their cesarean section using a midline vertical skin incision

Arm Title

High Transverse

Arm Type

Experimental

Arm Description

Patients in this arm will undergo their cesarean section using a high transverse skin incision, above the pannus

Intervention Type

Procedure

Intervention Name(s)

Midline Vertical

Intervention Description

Cesarean section performed using a midline vertical skin incision, located between the umbilicus and pubis

Intervention Type

Procedure

Intervention Name(s)

High Transverse

Intervention Description

Cesarean section performed using a transverse skin incision located above the pannus

Primary Outcome Measure Information:

Title

Wound Complications

Time Frame

6 months

10. Eligibility

Sex

Female

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: pre-pregnancy BMI equal or greater than 40 Exclusion Criteria: prior cesarean section or laparotomy

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Peter R Cole, MD

Phone

518-262-4942

colep@mail.amc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Olga T Filippova, MD

Phone

845-661-5716

filippo@mail.amc.edu

Facility Information:

Facility Name

Albany Medical Center Obstetrics and Gynecology

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter R Cole, MD

Phone

518-262-4942

colep@mail.amc.edu

Facility Name

Albany Medical Center Obstetrics and Gynecology

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter R Cole, MD

Phone

528-264-1800

colep@mail.amc.edu

Facility Name

Albany Medical Center

City

Albany

State/Province

New York

ZIP/Postal Code

12208

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter R Cole, MD

Phone

518-262-4131

colep@mail.amc.edu

Facility Name

Albany Medical Center Obstetrics and Gynecology

City

Ballston Spa

State/Province

New York

ZIP/Postal Code

12020

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter R Cole, MD

Phone

518-262-1200

colep@mail.amc.edu

Facility Name

Albany Medical Center Obstetrics and Gynecology

City

Clifton Park

State/Province

New York

ZIP/Postal Code

12065

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter R Cole, MD

Phone

518-264-1900

colep@mail.amc.edu

Facility Name

Albany Medical Center Obstetrics and Gynecology

City

Delmar

State/Province

New York

ZIP/Postal Code

12054

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter R Cole, MD

Phone

518-264-0701

colep@mail.amc.edu

Facility Name

Albany Medical Center Obstetrics and Gynecology

City

Latham

State/Province

New York

ZIP/Postal Code

12110

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Peter R Cole, MD

Phone

518-264-5053

colep@mail.amc.edu

12. IPD Sharing Statement

Plan to Share IPD

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Skin Incisions and Wound Complication Rates for C-sections in Obese Women

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