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 Orthopaedics1 site in 1 country494 target enrollmentMarch 21, 2017

ConditionsSurgical Incision

Overview

Phase: N/A
Intervention: Not specified
Conditions: Surgical Incision
Sponsor: Rothman Institute Orthopaedics
Enrollment: 494
Locations: 1
Primary Endpoint: Surgical Site Infection
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

March 21, 2017

End Date

March 2021

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Rothman Institute Orthopaedics

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patient ≥18 years old
•Male or non-pregnant, non-lactating, postmenopausal or surgically sterilized females
•Subjects undergoing revision total knee arthroplasty or revision total hip arthroplasty
•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
•Subjects deemed able to understand and comply with study visit schedule and procedures

Exclusion Criteria

•Wounds that require daily inspection
•Active bleeding within the surgical site
•Pregnant, lactating females, or females of childbearing potential not willing to practice an effective method of contraception
•Subjects on warfarin therapy. Resulting in increased exudate and prolonging hospital stay following surgery to achieve therapeutic INR levels
•Skin integrity issues that preclude the use of Negative Pressure Wound Therapy (NPWT)
•Subjects undergoing primary total joint procedures
•Subjects with a known history of poor compliance with medical treatment
•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)