Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass
Primary Purpose
Coronary Bypass Graft Stenosis of Autologous Vein
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
vacuum assisted closure
Axillary dissection
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Bypass Graft Stenosis of Autologous Vein
Eligibility Criteria
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
Sites / Locations
- Changhai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Vacuum assisted closure
Axillary dissection
Arm Description
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 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).
Outcomes
Primary Outcome Measures
Early Complications of Vascular Zone
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02010996
Brief Title
Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass
Official Title
Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass - a Randomized Control Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Changhai Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Bypass Graft Stenosis of Autologous Vein
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
72 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Vacuum assisted closure
Arm Type
Experimental
Arm Description
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.
Arm Title
Axillary dissection
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Procedure
Intervention Name(s)
vacuum assisted closure
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Axillary dissection
Intervention Description
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).
Primary Outcome Measure Information:
Title
Early Complications of Vascular Zone
Time Frame
2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hongda bi, Ph.D
Organizational Affiliation
Changhai Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhai Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200433
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
28099357
Citation
Yu Y, Song Z, Xu Z, Ye X, Xue C, Li J, Bi H. Bilayered negative-pressure wound therapy preventing leg incision morbidity in coronary artery bypass graft patients: A randomized controlled trial. Medicine (Baltimore). 2017 Jan;96(3):e5925. doi: 10.1097/MD.0000000000005925.
Results Reference
derived
Learn more about this trial
Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass
We'll reach out to this number within 24 hrs