A Prospective, Randomized, Comparative Study to Assess the Prevention of Surgical Site Infection (SSI's) in Revision Total Joint Arthroplasty Patients Treated With Single-Use Negative Pressure Wound Therapy (PICO) or Standard Care Dressings (AQUACEL Ag SURGICAL Dressing).

Last updated: June 6, 2017
Sponsor: Rothman Institute Orthopaedics
Overall Status: Active - Enrolling

Phase

N/A

Condition

Surgery

Pressure Ulcer

Treatment

N/A

Clinical Study ID

NCT03180346
16Chen02
  • Ages > 18
  • All Genders

Study Summary

The primary aim of this study is to determine if the SSI rate following revision total hip and knee arthroplasty is reduced in patients treated with the PICO device compared to patients with traditional postoperative dressings. Our secondary goals include; comparing the amount of wound drainage, rate of resolution of wound drainage, length of hospital stay, functional outcomes, and economic implications of wound drainage and SSI after revision arthroplasty comparing PICO and traditional dressings.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Patient ≥18 years old

  2. Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females

  3. Subjects undergoing revision total knee arthroplasty or revision total hiparthroplasty

  4. Subjects provide informed consent, which will consist of reading, signing, and datingthe informed consent document after the Investigator, sub-Investigator or otherdesignated study staff member has explained the study procedures, risks, and contactinformation

  5. Subjects deemed able to understand and comply with study visit schedule and procedures

Exclusion

Exclusion Criteria:

  1. Wounds that require daily inspection

  2. Active bleeding within the surgical site

  3. Pregnant, lactating females, or females of childbearing potential not willing topractice an effective method of contraception

  4. Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospitalstay following surgery to achieve therapeutic INR levels

  5. Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT)

  6. Subjects undergoing primary total joint procedures

  7. Subjects with a known history of poor compliance with medical treatment

  8. Subjects who have participated in this trial previously and who were withdrawn 9 .Subjects with known allergies to product components (silicone adhesives andpolyurethane films (direct contact with wound), acrylic adhesives (direct contact withskin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within thedressing)

Study Design

Total Participants: 494
Study Start date:
March 21, 2017
Estimated Completion Date:
March 31, 2021

Connect with a study center

  • Rothman Institute

    Philadelphia, Pennsylvania 19148
    United States

    Site Not Available

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