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 countryJanuary 2016

ConditionsSurgical Wound Infection

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Surgical Wound Infection
Sponsor: Rothman Institute Orthopaedics
Locations: 1
Primary Endpoint: Incidence of Surgical Site Infection
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The aim of this study is to assess the prevention of incision healing complications in patients undergoing revision TKA and THA treated with either Single-Use NPWT (PICO) compared to standard of care dressings (AQUACEL Ag Surgical Dressing). All patients undergoing a revision TKA and THA who consent to taking part in the study, and meet the eligibility criteria will be included onto the study. Patients will be followed up for a period of up to 3 months to determine if there are any latent incision healing complications

Registry

clinicaltrials.gov

Start Date

January 2016

End Date

February 2020

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)