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

Study Overview
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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.

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

Conditions
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Osteoarthritis

Intervention / Treatment
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* Combination Product: Antimicrobial Barrier Dressing
* Device: Negative Pressure Wound Therapy (NPWT)


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Antimicrobial Barrier Dressing<br>postoperative wound dressing with either anti-microbial dressing placed in the operating room from surgery to postoperative day 7 | Combination Product: Antimicrobial Barrier Dressing<br>* Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver.<br>* Other names: AQUACEL Ag Hydrofiber Dressing;|
| Active Comparator: Closed-incision Negative Pressure Therapy<br>portable NPWT device placed in the operating room from surgery to postoperative day 7 | Device: Negative Pressure Wound Therapy (NPWT)<br>* 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<br>* Other names: PICO;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) Pain Score | A patient is asked to indicate his/her perceived scar severity along a 100 mm horizontal line, and this rating is then measured from the left edge (=VAS score). The total score range is 0 (worst possible scar) to 100 (best possible scar); the higher the score, the better the scarring. | Day 8 | 
| Wound Evaluation Scale (WES) | WES is a 6-item scale. Items 1-5 are scored 0 (yes) or 1 (no), and item 6 is scored 0 (poor) or 1 (acceptable). The total score range is 0-6; the higher the score, the more optimal the wound healing. | Day 8 |