NCT01731769

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 19, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 22, 2012

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

November 22, 2012

Status Verified

November 1, 2012

Enrollment Period

Same day

First QC Date

November 19, 2012

Last Update Submit

November 19, 2012

Conditions

Breast Neoplasms

Keywords

Seroma FormationAxillary Lymph Node DissectionBreast cancerEarly Vacuum Assisted Closure

Outcome Measures

Primary Outcomes (1)

  • seroma formation complication incidence

    within the first 30 days (plus or minus 3 days) after surgery

Study Arms (2)

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

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 in experimental arm

Interventions

vacuum assisted closure in experimental armPROCEDURE
vacuum assisted closure
Axillary dissectionPROCEDURE
Axillary dissection

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Changhai Hospital

Shanghai, Shanghai Municipality, 200433, China

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Negative-Pressure Wound Therapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

DrainageTherapeuticsSurgical Procedures, OperativeWound Closure Techniques

Central Study Contacts

Hongda Bi, Ph.D

CONTACT

bihongda0411@yahoo.com.cn

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
attending physician,department of plastic surgery

Study Record Dates

First Submitted

November 19, 2012

First Posted

November 22, 2012

Study Start

January 1, 2013

Primary Completion

January 1, 2013

Study Completion

March 1, 2013

Last Updated

November 22, 2012

Record last verified: 2012-11

Locations

CN(1)