A Comparative Study to Assess the Prevention of Surgical... | NCT02664168

Studies
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

Sponsor

Rothman Institute Orthopaedics

Status

Unknown status

Last Update Posted

Apr 12, 2018Actual

Enrollment

Not provided

Phase

Not Applicable

Conditions

Surgical Wound Infection

Interventions

Aquacel Ag Surgical Dressing
Single-Use Negative Pressure Wound Therapy (PICO)

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Status Module

Record Verification Date

Apr 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2016

Primary Completion Date

Feb 2020Estimated

Completion Date

Not provided

First Submitted Date

Jan 22, 2016

First Submission Date that Met QC Criteria

Jan 25, 2016

First Posted Date

Jan 26, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 10, 2018

Last Update Posted Date

Apr 12, 2018Actual

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Aquacel Ag Surgical Dressing	Device		Aquacel Ag Surgical Dressing
Single-Use Negative Pressure Wound Therapy (PICO)

Measure	Description	Time Frame
Incidence of Surgical Site Infection		90 days post-op

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms