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NCT02901613 Clinical Trial

Prophylactic Post-Cesarean Incisional Negative-pressure Wound Therapy in Morbidly Obese Patients

Morbid Obesity Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02901613
Other study ID # AlbanyMC1
Secondary ID
Status Recruiting
Phase N/A
First received September 11, 2016
Last updated February 10, 2017
Start date August 2016
Est. completion date August 2017

Study information
Verified date February 2017
Source Albany Medical College
Contact Cassandra Denefrio, MD
Phone 5182645026
Email denefrc@mail.amc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 186
Est. completion date August 2017
Est. primary completion date August 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Negative-pressure wound therapy

Locations
Country Name City State
United States Albany Medical Center Albany New York

Sponsors (1)
Lead Sponsor Collaborator
Albany Medical College

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Wound complication 3 months
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