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Evaluation of Closed Incision Negative Pressure Dressing (PREVENA) to Prevent Lower Extremity Amputa

UCI Specialty Area: Surgery
Principal Investigator: Nii-Kabu Kabutey
Official Title: Evaluation of a Closed Incision Negative Pressure Dressing (PREVENA) To Prevent Lower Extremity Amputation Wound Complications
A Study On:
Amputation
Muscles and Bones - Musculoskeletal
Other
Traumatic Wounds

Study Description

This is a prospective, multi-center, two-arm, unblinded, randomized controlled trial to evaluate the impact of a closed incision negative pressure dressing (PREVENA™ PEEL & PLACE™ Dressing Kit) on incidence of post-operative wound complications in patients undergoing above-the-knee (AKA) or below-the-knee (BKA) amputation. Up to 440 subjects at approximately five (5) participating sites will be randomized to receive either the Prevena dressing or a standard care dressing. The incision will be assessed for complications at post-op day 5 or day 6 and at approximately 30 days after discharge. The primary outcome of this study is reported wound complications, including dehiscence (opening of the incision), seroma, lymph leak, infection (deep or superficial), hematoma (blood clots), ischemia (decreased blood supply), and necrosis (tissue death) A major complication is defined as any wound complication requiring intravenous or oral antibiotics, reoperation and/or hospital readmission. All data (demographics, medical history, and clinical outcomes) will be collected via medical record review

Eligibility

  1. Male or female adults 18 years or older
  2. Patients undergoing above-knee amputation (includes the revision of emergency guillotine amputations)
  3. Patients undergoing below-knee amputation (includes the revision of emergency guillotine amputations)
  4. Informed Consent signed by patient
  1. Minors under 18 years
  2. Women who are pregnant or breastfeeding
  3. Patients undergoing emergent or guillotine amputation
  4. Patients having BOTH legs amputated
  5. Patients with sensitivity to silver
  6. Unwilling or unable to provide informed consent
  7. Inability to comply with planned study procedures
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University of California, Irvine - Study Information Sheet

UCI Center for Clinical Research Potential Participant Database

Lead Researcher
Maheswari Senthil, MD
UCI Center for Clinical Research

In the instance of parental permission, “You” refers to “Your child.”

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