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

NYU Langone Health

Status and phase: Completed; Phase 3

Conditions: Osteoarthritis

Treatments: Device: Negative Pressure Wound Therapy (NPWT); Combination Product: Antimicrobial Barrier Dressing

Study type: Interventional

Funder types: Other

Identifiers

NCT03345771

17-00496

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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230 participants in 2 patient groups

Antimicrobial Barrier Dressing

Active Comparator group

Description:

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

Treatment:

Combination Product: Antimicrobial Barrier Dressing

Closed-incision Negative Pressure Therapy

Active Comparator group

Description:

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

Treatment:

Device: Negative Pressure Wound Therapy (NPWT)