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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT03180346
Other study ID # 16Chen02
Secondary ID
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
Health authority
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)

Study Design


Related Conditions & MeSH terms


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
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