search
Back to results

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
Changhai Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronary Bypass Graft Stenosis of Autologous Vein

Eligibility Criteria

10 Years - 80 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
December 3, 2013
Last Updated
September 30, 2014
Sponsor
Changhai Hospital
search

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