Trial Outcomes & Findings for Arista for ALT Donor Sites to Reduce Drain Output (NCT NCT02477774)
NCT ID: NCT02477774
Last Updated: 2022-09-22
Results Overview
The primary outcome analyzed in this study will be total drain output (mL) in an effort to determine if the addition of Arista to the wound bed decreases overall wound drainage and drain output.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
55 participants
Primary outcome timeframe
1-14 days after Surgery
Results posted on
2022-09-22
Participant Flow
Participant milestones
| Measure |
Arista
Arista to ALT donor site
ARISTA: According to the manufacturer, Arista uses Microporous Polysaccharide Hemospheres (MPH) technology to catalyze the clotting cascade and effectively dehydrate tissue to initiate hemostasis in broad areas. Major advantages of Arista are that it has been shown to be safe and effective across multiple surgical disciplines, is completely absorbed in 24-48 hours, and contains no human or animal components
|
Control
No Arista to ALT donor site
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
26
|
|
Overall Study
COMPLETED
|
29
|
26
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Arista
n=29 Participants
Arista to ALT donor site
ARISTA: According to the manufacturer, Arista uses Microporous Polysaccharide Hemospheres (MPH) technology to catalyze the clotting cascade and effectively dehydrate tissue to initiate hemostasis in broad areas. Major advantages of Arista are that it has been shown to be safe and effective across multiple surgical disciplines, is completely absorbed in 24-48 hours, and contains no human or animal components
|
Control
n=26 Participants
No Arista to ALT donor site
|
Total
n=55 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65 years
STANDARD_DEVIATION 12 • n=29 Participants
|
64 years
STANDARD_DEVIATION 13 • n=26 Participants
|
64 years
STANDARD_DEVIATION 12 • n=55 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=29 Participants
|
4 Participants
n=26 Participants
|
14 Participants
n=55 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=29 Participants
|
22 Participants
n=26 Participants
|
41 Participants
n=55 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 1-14 days after SurgeryThe primary outcome analyzed in this study will be total drain output (mL) in an effort to determine if the addition of Arista to the wound bed decreases overall wound drainage and drain output.
Outcome measures
| Measure |
Arista
n=29 Participants
Arista to ALT donor site
ARISTA: According to the manufacturer, Arista uses Microporous Polysaccharide Hemospheres (MPH) technology to catalyze the clotting cascade and effectively dehydrate tissue to initiate hemostasis in broad areas. Major advantages of Arista are that it has been shown to be safe and effective across multiple surgical disciplines, is completely absorbed in 24-48 hours, and contains no human or animal components
|
Control
n=26 Participants
No Arista to ALT donor site
|
|---|---|---|
|
Total Drain Output
|
284 ml
Standard Deviation 153
|
317 ml
Standard Deviation 178
|
PRIMARY outcome
Timeframe: 30 days postoperativeALT donor site will be evaluated for seroma
Outcome measures
| Measure |
Arista
n=29 Participants
Arista to ALT donor site
ARISTA: According to the manufacturer, Arista uses Microporous Polysaccharide Hemospheres (MPH) technology to catalyze the clotting cascade and effectively dehydrate tissue to initiate hemostasis in broad areas. Major advantages of Arista are that it has been shown to be safe and effective across multiple surgical disciplines, is completely absorbed in 24-48 hours, and contains no human or animal components
|
Control
n=26 Participants
No Arista to ALT donor site
|
|---|---|---|
|
Number of Participants With the Development of ALT Donor Site Seroma
|
6 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: 30 days postoperativeGiven that drain output influences time of drain removal, assessment will be made to determine if timing of drain removal differs between groups.
Outcome measures
| Measure |
Arista
n=29 Participants
Arista to ALT donor site
ARISTA: According to the manufacturer, Arista uses Microporous Polysaccharide Hemospheres (MPH) technology to catalyze the clotting cascade and effectively dehydrate tissue to initiate hemostasis in broad areas. Major advantages of Arista are that it has been shown to be safe and effective across multiple surgical disciplines, is completely absorbed in 24-48 hours, and contains no human or animal components
|
Control
n=26 Participants
No Arista to ALT donor site
|
|---|---|---|
|
Timing to Drain Removal
|
5.9 days
Standard Deviation 1.5
|
6.5 days
Standard Deviation 1.6
|
SECONDARY outcome
Timeframe: 30 days postoperativePopulation: Hospital Length of Stay data were not collected.
Will eval hospital length of stay for both groups
Outcome measures
Outcome data not reported
Adverse Events
Arista
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place