Trial Outcomes & Findings for Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass (NCT NCT02010996)
NCT ID: NCT02010996
Last Updated: 2014-10-03
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
72 participants
Primary outcome timeframe
2 weeks
Results posted on
2014-10-03
Participant Flow
Participant milestones
| Measure |
Vacuum Assisted Closure
Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.
vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.
|
Axillary Dissection
Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
|
|---|---|---|
|
Overall Study
STARTED
|
36
|
36
|
|
Overall Study
COMPLETED
|
36
|
36
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass
Baseline characteristics by cohort
| Measure |
Vacuum Assisted Closure
n=36 Participants
Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.
vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.
|
Axillary Dissection
n=36 Participants
Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
|
Total
n=72 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.4 years
STANDARD_DEVIATION 10.2 • n=99 Participants
|
55.4 years
STANDARD_DEVIATION 12.4 • n=107 Participants
|
56.4 years
STANDARD_DEVIATION 11.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
25 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
diabetes
yes
|
17 participants
n=99 Participants
|
16 participants
n=107 Participants
|
33 participants
n=206 Participants
|
|
diabetes
no
|
19 participants
n=99 Participants
|
20 participants
n=107 Participants
|
39 participants
n=206 Participants
|
|
carotid artery stenosis
yes
|
5 participants
n=99 Participants
|
4 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
carotid artery stenosis
no
|
31 participants
n=99 Participants
|
32 participants
n=107 Participants
|
63 participants
n=206 Participants
|
|
smoking
yes
|
20 participants
n=99 Participants
|
21 participants
n=107 Participants
|
41 participants
n=206 Participants
|
|
smoking
no
|
16 participants
n=99 Participants
|
15 participants
n=107 Participants
|
31 participants
n=206 Participants
|
|
obesity
yes
|
8 participants
n=99 Participants
|
6 participants
n=107 Participants
|
14 participants
n=206 Participants
|
|
obesity
no
|
28 participants
n=99 Participants
|
30 participants
n=107 Participants
|
58 participants
n=206 Participants
|
|
glucocorticoid
yes
|
1 participants
n=99 Participants
|
0 participants
n=107 Participants
|
1 participants
n=206 Participants
|
|
glucocorticoid
no
|
35 participants
n=99 Participants
|
36 participants
n=107 Participants
|
71 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 2 weeksOutcome measures
| Measure |
Vacuum Assisted Closure(Thigh)
n=36 Participants
Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.
vacuum assisted closure: Vacuum assisted closure (also called vacuum therapy, vacuum sealing or topical negative pressure therapy) is a sophisticated development of a standard surgical procedure, the use of vacuum assisted drainage to remove blood or serous fluid from a wound or operation site.
|
Axillary Dissection(Thigh)
n=36 Participants
Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
Axillary dissection: Axillary dissection is a surgical procedure that incises (opens) the armpit (axilla or axillary) to identify, examine, or remove lymph nodes (small glands, part of the lymphatic system, which filters cellular fluids).
|
Vacuum Assisted Closure(Shank)
n=36 Participants
|
Axillary Dissection(Shank)
n=36 Participants
|
|---|---|---|---|---|
|
Early Complications of Vascular Zone
|
1 participants
|
4 participants
|
15 participants
|
5 participants
|
Adverse Events
Vacuum Assisted Closure(Thigh)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Axillary Dissection(Thigh)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Vacuum Assisted Closure(Shank)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Axillary Dissection(Shank)
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