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).

NCT03180346 | Unknown

• 1 other identifier: 16Chen02
• Study Type: interventional
• Target: 494
• Locations: 1 country
• Sites: 1

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.

Conditions

Surgical Incision

Outcome Measures

Primary Outcomes (1)

• Surgical Site Infection

  90-day followup following revision surgery

Study Arms (2)

Single-Use Negative Pressure Wound Therapy

ACTIVE COMPARATOR

Device: PICO

Standard of Care

ACTIVE COMPARATOR

Device: Aquacel

Interventions

PICO DEVICE

Single Use Negative Pressure Dressing

Single-Use Negative Pressure Wound Therapy

Aquacel DEVICE

Occlusive surgical dressing infused with ionized silver

Standard of Care

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, 19148, United States

Location

MeSH Terms

Conditions

Surgical Wound

Condition Hierarchy (Ancestors)

Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 6, 2017
• First Posted: June 8, 2017
• Study Start: March 21, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2021
• Last Updated: June 8, 2017

Record last verified: 2017-06

Locations

US (1)