Back to resultsProphylactic Post-Cesarean Incisional Negative-pressure Wound Therapy in Morbidly Obese Patients
Primary Purpose
Negative-pressure Wound Therapy, Morbid Obesity, Cesarean Section
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Negative-pressure wound therapy
Sponsored by
About this trial
This is an interventional prevention trial for Negative-pressure Wound Therapy
Eligibility Criteria
Inclusion Criteria:
- Women undergoing cesarean section at Albany Medical Center Hospital
- Current BMI greater than or equal to 40
Exclusion Criteria:
- Current BMI less than 40
- current skin or soft tissue infection
- skin or soft tissue disorder
- allergy to silver
Sites / Locations
- Albany Medical CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Retrospective
Prospective
Arm Description
Standard dry sterile dressing
Negative-pressure wound therapy
Outcomes
Primary Outcome Measures
Wound complication
Secondary Outcome Measures
Full Information
NCT ID
NCT02901613
First Posted
September 11, 2016
Last Updated
February 10, 2017
Sponsor
Albany Medical College
1. Study Identification
Unique Protocol Identification Number
NCT02901613
Brief Title
Prophylactic Post-Cesarean Incisional Negative-pressure Wound Therapy in Morbidly Obese Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 2016 (undefined)
Primary Completion Date
August 2017 (Anticipated)
Study Completion Date
August 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albany Medical College
4. Oversight
5. Study Description
Brief Summary
To evaluate the effectiveness of negative-pressure wound therapy in decreasing wound complications in morbidly obese patients (BMI greater than of equal to 40) at Albany Medical Center Hospital. Retrospective data will be collected regarding morbidly obese patients who have undergone cesarean section and patients will be recruited to have the intervention (negative-pressure wound therapy) applied and outcomes will be evaluated.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Negative-pressure Wound Therapy, Morbid Obesity, Cesarean Section, Wound Infection
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
186 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Retrospective
Arm Type
No Intervention
Arm Description
Standard dry sterile dressing
Arm Title
Prospective
Arm Type
Experimental
Arm Description
Negative-pressure wound therapy
Intervention Type
Device
Intervention Name(s)
Negative-pressure wound therapy
Primary Outcome Measure Information:
Title
Wound complication
Time Frame
3 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women undergoing cesarean section at Albany Medical Center Hospital
Current BMI greater than or equal to 40
Exclusion Criteria:
Current BMI less than 40
current skin or soft tissue infection
skin or soft tissue disorder
allergy to silver
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cassandra Denefrio, MD
Phone
5182645026
Email
denefrc@mail.amc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Cole, MD
Organizational Affiliation
Albany Medical College
Official's Role
Principal Investigator
Facility Information:
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
518-264-5026
Email
colep@mail.amc.edu
12. IPD Sharing Statement
Learn more about this trial
Prophylactic Post-Cesarean Incisional Negative-pressure Wound Therapy in Morbidly Obese Patients
We'll reach out to this number within 24 hrs