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).

Surgical Incision Clinical Trial

Official title:

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).

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03180346
• Other study ID #: 16Chen02
• Status: Enrolling by invitation
• Phase: N/A
• First received: June 6, 2017
• Last updated: June 6, 2017
• Start date: March 21, 2017
• Est. completion date: March 2021

Study information

• Verified date: June 2017
• Source: Rothman Institute Orthopaedics
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 494
• Est. completion date: March 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Surgical Incision
• Surgical Wound Infection

Intervention

Device:
• PICO
Single Use Negative Pressure Dressing
• Aquacel
Occlusive surgical dressing infused with ionized silver

Locations

Country	Name	City	State
United States	Rothman Institute	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Rothman Institute Orthopaedics

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Surgical Site Infection		90-day followup following revision surgery