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)

Surgical Wound Infection 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: Recruiting

Administrative data

• NCT number: NCT02664168
• Other study ID #: 2016Jpar01
• Status: Recruiting
• Phase: N/A
• First received: January 22, 2016
• Last updated: April 10, 2018
• Start date: January 2016

Study information

• Verified date: April 2018
• Source: Rothman Institute Orthopaedics
• Contact: Tiffany Morrison, MS
• Phone: 267-339-7818
• Email: tiffany.morrison[@]rothmaninstitute.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 0
• Est. primary completion date: February 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

• Communicable Diseases
• Infection
• Surgical Wound
• Surgical Wound Infection
• Wound Infection
• Wounds and Injuries

Intervention

Device:
• Aquacel Ag Surgical Dressing

• Single-Use Negative Pressure Wound Therapy (PICO)

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	Incidence of Surgical Site Infection		90 days post-op