Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass

NCT ID: NCT02010996

Last Updated: 2014-10-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

72 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-04-30

Brief Summary

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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

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Conditions

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Coronary Bypass Graft Stenosis of Autologous Vein

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

vacuum assisted closure

Intervention Type PROCEDURE

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).

Group Type ACTIVE_COMPARATOR

Axillary dissection

Intervention Type PROCEDURE

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).

Interventions

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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.

Intervention Type PROCEDURE

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).

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bi-Hongda

physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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hongda bi, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Changhai Hospital

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

References

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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.

Reference Type DERIVED
PMID: 28099357 (View on PubMed)

Other Identifiers

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PSF20131201

Identifier Type: -

Identifier Source: org_study_id

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