Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass

Not Applicable

Completed

• Conditions: Coronary Bypass Graft Stenosis of Autologous Vein
• Interventions: Procedure: vacuum assisted closure; Procedure: Axillary dissection

• Registration Number: NCT02010996
• Lead Sponsor: Changhai Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12
• Study First Submitted: 2013-12-03
• Study First Submitted QC: 2013-12-10
• Study First Posted: 2013-12-13
• Primary Completion: 2014-04
• Study Completion: 2014-04
• Status Verified: 2014-09
• Results First Submitted: 2014-09-30
• Results First Submitted QC: 2014-09-30
• Last Update Submitted: 2014-09-30
• Results First Posted: 2014-10-03
• Last Update Posted: 2014-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vacuum assisted closure	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	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 Measures

Name	Time	Method
Early Complications of Vascular Zone	2 weeks

Trial Locations

Locations (1)

Changhai Hospital; 🇨🇳 Shanghai, Shanghai, China