Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- NYU Langone Health
- Enrollment
- 230
- Locations
- 1
- Primary Endpoint
- Visual Analog Scale (VAS) Pain Score
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Outcomes
Primary Outcomes
Visual Analog Scale (VAS) Pain Score
Time Frame: Day 8
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.
Wound Evaluation Scale (WES)
Time Frame: Day 8
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.
Secondary Outcomes
No secondary outcomes reported