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

Not Applicable

• Conditions: Negative-pressure Wound Therapy; Cesarean Section; Wound Infection; Morbid Obesity
• Interventions: Device: Negative-pressure wound therapy

• Registration Number: NCT02901613
• Lead Sponsor: Albany Medical College

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-08
• Study First Submitted: 2016-09-11
• Study First Submitted QC: 2016-09-14
• Study First Posted: 2016-09-15
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-10
• Last Update Posted: 2017-02-13
• Primary Completion: 2017-08
• Study Completion: 2017-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 186

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective	Negative-pressure wound therapy	Negative-pressure wound therapy

Primary Outcome Measures

Name	Time	Method
Wound complication	3 months

Trial Locations

Locations (1)

Albany Medical Center; 🇺🇸 Albany, New York, United States