Coronary Bypass Graft Stenosis of Autologous Vein
Conditions
Brief summary
The great saphenous vein is the most commonly used material in coronary vascular bridging operation. Coronary bypass operation to obtain the great saphenous vein is mainly through the incision open groin to ankle. This operation may damage the lymphatic, cause lymph circumfluence obstacle, cause fat liquefaction, scar formation, wound dehiscence, around hematoma and other a series of symptoms.Based on some studies and our experience that vacuum assisted closure （VAC）is effective in complex wound failures following Stripping saphenous vein, we use VAC to prevent seroma formation after Stripping saphenous vein in Coronary bypass. This study is aimed to evaluate the efficacy and economics benefits of early VAC application on postoperative complications and wound healing after Stripping saphenous vein in Coronary bypass in comparison to conventional suction drain.
Interventions
PROCEDUREvacuum 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.
PROCEDUREAxillary 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).
Sponsors
Changhai Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent * Coronary heart disease patients to transplant more than 2 vascular bridge * The thigh groin following from the saphenous vein
Exclusion criteria
* Subjects does not agree to participate in clinical trials * Subjects had a injury, operation history of Thigh * Subjects having ever received chemotherapy before the surgery * Subjects with known hypersensitivity to components of the surgical sticky membrane
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Early Complications of Vascular Zone | 2 weeks |
Countries
China
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 36 |
| 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). | 36 |
| Total | 72 |
Baseline characteristics
| Characteristic | Vacuum Assisted Closure | Axillary Dissection | Total |
|---|---|---|---|
| Age, Continuous | 58.4 years STANDARD_DEVIATION 10.2 | 55.4 years STANDARD_DEVIATION 12.4 | 56.4 years STANDARD_DEVIATION 11.6 |
| carotid artery stenosis no | 31 participants | 32 participants | 63 participants |
| carotid artery stenosis yes | 5 participants | 4 participants | 9 participants |
| diabetes no | 19 participants | 20 participants | 39 participants |
| diabetes yes | 17 participants | 16 participants | 33 participants |
| glucocorticoid no | 35 participants | 36 participants | 71 participants |
| glucocorticoid yes | 1 participants | 0 participants | 1 participants |
| obesity no | 28 participants | 30 participants | 58 participants |
| obesity yes | 8 participants | 6 participants | 14 participants |
| Sex: Female, Male Female | 11 Participants | 13 Participants | 24 Participants |
| Sex: Female, Male Male | 25 Participants | 23 Participants | 48 Participants |
| smoking no | 16 participants | 15 participants | 31 participants |
| smoking yes | 20 participants | 21 participants | 41 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 |
| serious Total, serious adverse events | 0 / 36 | 0 / 36 | 0 / 36 | 0 / 36 |
Outcome results
Primary
Early Complications of Vascular Zone
Time frame: 2 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vacuum Assisted Closure(Thigh) | Early Complications of Vascular Zone | 1 participants |
| Axillary Dissection(Thigh) | Early Complications of Vascular Zone | 4 participants |
| Vacuum Assisted Closure(Shank) | Early Complications of Vascular Zone | 15 participants |
| Axillary Dissection(Shank) | Early Complications of Vascular Zone | 5 participants |
p-value: 0.05Chi-squared