Phase 3
N=230
Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty
Osteoarthritis
Bottom Line
View on ClinicalTrials.gov: NCT03345771 ↗Enrolled (actual)
230
Serious AEs
1.3%
Results posted
Apr 2022
Primary outcome: Primary: Visual Analog Scale (VAS) Pain Score — 64; 61 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Antimicrobial Barrier Dressing (Combination_product); Negative Pressure Wound Therapy (NPWT) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- NYU Langone Health
- Primary completion
- Apr 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Visual Analog Scale (VAS) Pain Score |
64; 61 | — |
| PRIMARY Wound Evaluation Scale (WES) |
4.3; 4.2 | — |
Summary
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT03345771). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.