Osteoarthritis
Conditions
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.
Interventions
COMBINATION_PRODUCTAntimicrobial Barrier Dressing
Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver.
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
Sponsors
NYU Langone Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Visual Analog Scale (VAS) Pain Score | 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) | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Antimicrobial Barrier Dressing postoperative wound dressing with either anti-microbial dressing placed in the operating room from surgery to postoperative day 7
Antimicrobial Barrier Dressing: Ionic Silver is a soft, nonwoven pad or ribbon that features the gelling benefits of Hydrofiber technology plus antimicrobial ionic silver. | 115 |
| Closed-incision Negative Pressure Therapy portable NPWT device placed in the operating room from surgery to postoperative day 7
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 | 115 |
| Total | 230 |
Baseline characteristics
| Characteristic | Antimicrobial Barrier Dressing | Total | Closed-incision Negative Pressure Therapy |
|---|---|---|---|
| Age, Continuous | 59.87 years STANDARD_DEVIATION 9.84 | 60.24 years STANDARD_DEVIATION 9.56 | 60.87 years STANDARD_DEVIATION 9.32 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 115 Participants | 230 Participants | 115 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 115 participants | 230 participants | 115 participants |
| Sex: Female, Male Female | 33 Participants | 66 Participants | 33 Participants |
| Sex: Female, Male Male | 82 Participants | 164 Participants | 82 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 115 | 0 / 115 |
| other Total, other adverse events | 6 / 115 | 2 / 115 |
| serious Total, serious adverse events | 3 / 115 | 0 / 115 |
Outcome results
Primary
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antimicrobial Barrier Dressing | Visual Analog Scale (VAS) Pain Score | 64 score on a scale | Standard Deviation 26 |
| Closed-incision Negative Pressure Therapy | Visual Analog Scale (VAS) Pain Score | 61 score on a scale | Standard Deviation 24 |
Primary
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.
Time frame: Day 8
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Antimicrobial Barrier Dressing | Wound Evaluation Scale (WES) | 4.3 score on a scale | Standard Deviation 1.3 |
| Closed-incision Negative Pressure Therapy | Wound Evaluation Scale (WES) | 4.2 score on a scale | Standard Deviation 1.7 |