Trial Outcomes & Findings for Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty (NCT NCT03345771)
NCT ID: NCT03345771
Last Updated: 2022-04-22
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
230 participants
Primary outcome timeframe
Day 8
Results posted on
2022-04-22
Participant Flow
Participant milestones
| Measure |
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.
|
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
|
|---|---|---|
|
Overall Study
STARTED
|
115
|
115
|
|
Overall Study
COMPLETED
|
115
|
115
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Antimicrobial Barrier Dressing Versus Closed-incision Negative Pressure Therapy in the Obese Primary Total Joint Arthroplasty
Baseline characteristics by cohort
| Measure |
Antimicrobial Barrier Dressing
n=115 Participants
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.
|
Closed-incision Negative Pressure Therapy
n=115 Participants
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
|
Total
n=230 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
59.87 years
STANDARD_DEVIATION 9.84 • n=5 Participants
|
60.87 years
STANDARD_DEVIATION 9.32 • n=7 Participants
|
60.24 years
STANDARD_DEVIATION 9.56 • n=5 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
82 Participants
n=5 Participants
|
82 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
115 Participants
n=5 Participants
|
115 Participants
n=7 Participants
|
230 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
115 participants
n=5 Participants
|
115 participants
n=7 Participants
|
230 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Day 8A 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.
Outcome measures
| Measure |
Antimicrobial Barrier Dressing
n=78 Participants
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.
|
Closed-incision Negative Pressure Therapy
n=81 Participants
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
|
|---|---|---|
|
Visual Analog Scale (VAS) Pain Score
|
64 score on a scale
Standard Deviation 26
|
61 score on a scale
Standard Deviation 24
|
PRIMARY outcome
Timeframe: Day 8WES 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.
Outcome measures
| Measure |
Antimicrobial Barrier Dressing
n=50 Participants
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.
|
Closed-incision Negative Pressure Therapy
n=42 Participants
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
|
|---|---|---|
|
Wound Evaluation Scale (WES)
|
4.3 score on a scale
Standard Deviation 1.3
|
4.2 score on a scale
Standard Deviation 1.7
|
Adverse Events
Antimicrobial Barrier Dressing
Serious events: 3 serious events
Other events: 6 other events
Deaths: 0 deaths
Closed-incision Negative Pressure Therapy
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Antimicrobial Barrier Dressing
n=115 participants at risk
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.
|
Closed-incision Negative Pressure Therapy
n=115 participants at risk
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
|
|---|---|---|
|
Surgical and medical procedures
Irrigation and Debridement
|
1.7%
2/115 • 90 days
Study members will monitor the participants for adverse events on an ongoing basis
|
0.00%
0/115 • 90 days
Study members will monitor the participants for adverse events on an ongoing basis
|
|
Surgical and medical procedures
Revision Total Knee Arthroplasty
|
0.87%
1/115 • 90 days
Study members will monitor the participants for adverse events on an ongoing basis
|
0.00%
0/115 • 90 days
Study members will monitor the participants for adverse events on an ongoing basis
|
Other adverse events
| Measure |
Antimicrobial Barrier Dressing
n=115 participants at risk
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.
|
Closed-incision Negative Pressure Therapy
n=115 participants at risk
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
|
|---|---|---|
|
Surgical and medical procedures
Wound drainage
|
4.3%
5/115 • 90 days
Study members will monitor the participants for adverse events on an ongoing basis
|
1.7%
2/115 • 90 days
Study members will monitor the participants for adverse events on an ongoing basis
|
|
Surgical and medical procedures
Non-healing wound
|
0.87%
1/115 • 90 days
Study members will monitor the participants for adverse events on an ongoing basis
|
0.00%
0/115 • 90 days
Study members will monitor the participants for adverse events on an ongoing basis
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place