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)

NCT02664168 | Unknown

• 1 other identifier: 2016Jpar01
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Conditions

Surgical Wound Infection

Outcome Measures

Primary Outcomes (1)

• Incidence of Surgical Site Infection

  90 days post-op

Study Arms (2)

Aquacel Ag Surgical Dressing

ACTIVE COMPARATOR

Device: Aquacel Ag Surgical Dressing

Single-Use Negative Pressure Wound Therapy (PICO)

ACTIVE COMPARATOR

Device: Single-Use Negative Pressure Wound Therapy (PICO)

Interventions

Aquacel Ag Surgical Dressing DEVICE

Aquacel Ag Surgical Dressing

Single-Use Negative Pressure Wound Therapy (PICO) DEVICE

Single-Use Negative Pressure Wound Therapy (PICO)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Rothman Institute Orthopaedics: lead

Study Sites (1)

Rothman Institute

Philadelphia, Pennsylvania, 19107, United States

RECRUITING

MeSH Terms

Conditions

Surgical Wound Infection

Condition Hierarchy (Ancestors)

Wound Infection; Infections; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Tiffany Morrison, MS

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2016
• First Posted: January 26, 2016
• Study Start: January 1, 2016
• Primary Completion: February 1, 2020
• Last Updated: April 12, 2018

Record last verified: 2018-04

Locations

US (1)