Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

230 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-11-13

Study Completion Date

2021-06-01

Brief Summary

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The purpose of this study is to determine whether an occlusive antimicrobial barrier dressing or portable negative pressure wound dressing is superior in preventing wound complications and infection rates in obese patients undergoing total joint arthroplasty (TJA). Approximately 240 subjects (120 for total knee arthroplasty and 120 for total hip arthroplasty) will be enrolled to evaluate the outcomes associated with silver impregnated dressings and negative pressure wound therapy (NPWT) in treating this subset of patients and analyze the cost benefit of each.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Antimicrobial Barrier Dressing

postoperative wound dressing with either anti-microbial dressing placed in the operating room from surgery to postoperative day 7

Group Type ACTIVE_COMPARATOR

Antimicrobial Barrier Dressing

Intervention Type COMBINATION_PRODUCT

Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver.

Closed-incision Negative Pressure Therapy

portable NPWT device placed in the operating room from surgery to postoperative day 7

Group Type ACTIVE_COMPARATOR

Negative Pressure Wound Therapy (NPWT)

Intervention Type DEVICE

PICO provides suction known as negative Pressure wound Therapy (NPWT) which draws out excess fluid from a wound and protects the injured area from getting dirty to ultimately help promote healing. PICO consists of an nPwT pump connected to an absorbent gentle adhesive dressing

Interventions

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Antimicrobial Barrier Dressing

Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver.

Intervention Type COMBINATION_PRODUCT

Negative Pressure Wound Therapy (NPWT)

PICO provides suction known as negative Pressure wound Therapy (NPWT) which draws out excess fluid from a wound and protects the injured area from getting dirty to ultimately help promote healing. PICO consists of an nPwT pump connected to an absorbent gentle adhesive dressing

Intervention Type DEVICE

Other Intervention Names

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AQUACEL Ag Hydrofiber Dressing PICO

Eligibility Criteria

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Inclusion Criteria

* Those identified at pre-operative testing to have an elevated BMI (\> 35)

Exclusion Criteria

* Active infection
* previous scar or wound healing complication
* post traumatic degenerative joint disease (DJD) with hardware
* revision surgery
* inflammatory arthritis
* anticoagulation outside of the standard of care.

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No