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

NCT ID: NCT01731769

Last Updated: 2012-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-01-31

Study Completion Date

2013-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Neoplasms

Keywords

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Seroma Formation Axillary Lymph Node Dissection Breast cancer Early Vacuum Assisted Closure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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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

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 in experimental arm

Intervention Type PROCEDURE

Interventions

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vacuum assisted closure in experimental arm

Intervention Type PROCEDURE

Axillary dissection

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Changhai Hospital

OTHER

Sponsor Role lead

Responsible Party

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Bi-Hongda

attending physician,department of plastic surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Changhai Hospital

Shanghai, Shanghai Municipality, China

Site Status

Countries

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China

Central Contacts

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Hongda Bi, Ph.D

Role: CONTACT

Email: [email protected]

Facility Contacts

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Hongda Bi, Ph.D

Role: primary

Other Identifiers

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PSF-2012

Identifier Type: -

Identifier Source: org_study_id