Preventing Seroma Formation After Stripping Saphenous Vein in Coronary Bypass

NCT02010996 | Completed Results

• 1 other identifier: PSF20131201
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Bypass Graft Stenosis of Autologous Vein

Outcome Measures

Primary Outcomes (1)

• Early Complications of Vascular Zone

  2 weeks

Study Arms (2)

Vacuum assisted closure

EXPERIMENTAL

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.

Procedure: vacuum assisted closure

Axillary dissection

ACTIVE COMPARATOR

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).

Procedure: Axillary dissection

Interventions

vacuum assisted closure 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.

Vacuum assisted closure

Axillary dissection 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).

Axillary dissection

Eligibility Criteria

• Age: 10 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Written informed consent
• Coronary heart disease patients to transplant more than 2 vascular bridge
• The thigh groin following from the saphenous vein

You may not qualify if:

• 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

Sponsors & Collaborators

• Changhai Hospital: lead

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

Related Publications (1)

• 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.

  PMID: 28099357 DERIVED

MeSH Terms

Interventions

Negative-Pressure Wound Therapy

Intervention Hierarchy (Ancestors)

Drainage; Therapeutics; Surgical Procedures, Operative; Wound Closure Techniques

Results Point of Contact

• Title: Bi-Hongda
• Organization: changhai hospital

bihongda0411@yahoo.com.cn

86-13918233009

Study Officials

• hongda bi, Ph.D

  Changhai Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: physician

Study Record Dates

• First Submitted: December 3, 2013
• First Posted: December 13, 2013
• Study Start: December 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: October 3, 2014
• Results First Posted: October 3, 2014

Record last verified: 2014-09

Locations

CN (1)