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).

Rothman Institute Orthopaedics

Status: Unknown

Conditions: Surgical Incision

Treatments: Device: Aquacel; Device: PICO

Study type: Interventional

Funder types: Other

Identifiers

NCT03180346

16Chen02

Details and patient eligibility

About

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.

Enrollment: 494 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 hip arthroplasty
4. Subjects provide informed consent, which will consist of reading, signing, and dating the informed consent document after the Investigator, sub-Investigator or other designated study staff member has explained the study procedures, risks, and contact information
5. Subjects deemed able to understand and comply with study visit schedule and procedures

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 to practice an effective method of contraception
4. Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospital stay 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 Subjects who have participated in this trial previously and who were withdrawn 9 .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 and polyurethane films (direct contact with wound), acrylic adhesives (direct contact with skin), polyethylene fabrics and super-absorbent powders (polyacrylates) (within the dressing)

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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494 participants in 2 patient groups

Single-Use Negative Pressure Wound Therapy

Active Comparator group

Treatment:

Device: PICO

Standard of Care

Active Comparator group

Treatment:

Device: Aquacel