Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure

Breast Neoplasms Clinical Trial

Official title:

Preventing Seroma Formation After Axillary Lymph Node Dissection for Breast Cancer by Early Vacuum Assisted Closure--- a Randomized Control Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01731769
• Other study ID #: PSF-2012
• Status: Not yet recruiting
• Phase: N/A
• First received: November 19, 2012
• Last updated: November 19, 2012
• Start date: January 2013
• Est. completion date: March 2013

Study information

• Verified date: November 2012
• Source: Changhai Hospital
• Contact: Hongda Bi, Ph.D
• Email: bihongda0411[@]yahoo.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

Axillary dissection is the standard treatment for breast cancer patients with positive nodes. However, seroma formation after axillary dissection remains the most common early complication to breast cancer surgery. It can delay the initiation of adjuvant therapy, predispose to wound infection, delay wound healing and has also been linked to arm lymphoedema. Based on some studies and our experience that vacuum assisted closure （VAC）is effective in complex wound failures following axillary dissection and groin dissection, we use VAC to prevent seroma formation after extensive axillary dissection. This study is aimed to evaluate the efficacy, safety and economics benefits of early VAC application on postoperative complications and wound healing after extensive axillary dissection in comparison to conventional suction drain.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Written informed consent

• patients diagnosed with breast cancer, receiving modified radical mastectomy and axillary dissection;

• Body Mass Index =28;

• drainage volume within the first 48 hours is more than 200 mL.

Exclusion Criteria:

• Subjects with coagulation disorders shown by exceeding the normal range of any of following: prothrombin time (PT), Quick, activated partial thromboplastin time (aPTT), fibrinogen level, or thrombocytes.

• Subjects having previously had axillary surgery,

• Subjects having undergone irradiation therapy to the axillary tissue

• Subjects having ever received chemotherapy before the surgery,

• Subjects with known hypersensitivity to components of the surgical sticky membrane

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Procedure:
• vacuum assisted closure in experimental arm

• Axillary dissection

Locations

Country	Name	City	State
China	Changhai Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Changhai Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seroma formation complication incidence		within the first 30 days (plus or minus 3 days) after surgery	Yes