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A 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) | Clinical Trials | Clareo Health

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A 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)

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)

NCT02664168•Rothman Institute Orthopaedics

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

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)

Locations (1)

Rothman Institute

Philadelphia, Pennsylvania, United States

Key Dates

Start Date

January 1, 2016

Primary Completion Date

February 1, 2020

Last Updated

April 12, 2018

Conditions

Surgical Wound Infection

Interventions

Aquacel Ag Surgical Dressing

DEVICE

Single-Use Negative Pressure Wound Therapy (PICO)

DEVICE

Contacts

Tiffany Morrison, MS

CONTACT

267-339-7818 tiffany.morrison@rothmaninstitute.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 12, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A 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)

Inclusion Criteria

Exclusion Criteria

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