Effects of Prevena Therapy on Obese and or Diabetic Patients With Surgical Groin Sites

Dr. Jean E. Starr, MD

Status: Unknown

Conditions: Diabetes; Peripheral Vascular Disease; Obesity

Treatments: Device: Prevena vac

Study type: Interventional

Funder types: Other

Identifiers

NCT01983215

2013H0045

Details and patient eligibility

About

The purpose of the study is to determine the effects of Prevena therapy on decreasing groin surgical site infections in patients who are obese and /or diabetic having vascular surgery.

Full description

Patients who are obese and/or diabetic may have poor surgical healing and infection rates higher. The PREVENA therapy will be used to evaluate possible reduction of infection rates in this patient population

Enrollment: 276 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• subjects over 18 years old
• obese (BMI > 30) and or diabetic

Exclusion criteria

• current infected surgical field, hemodialysis, immunosuppressive therapy, allergy to adhesive, sensitivity to silver

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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276 participants in 1 patient group

negative pressure dressing vs. standard of care

Experimental group

Description:

single arm study- randomized Prevena vac or standard of care

Treatment:

Device: Prevena vac