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NCT03104153 Clinical Trial

Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection

Breast Cancer Clinical Trial

Official title:
Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection on Clinical Outcome and Quality of Life in Breast Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03104153
Other study ID # S58129
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 2015
Est. completion date June 30, 2016

Study information
Verified date March 2017
Source Universitaire Ziekenhuizen KU Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

To compare early drain removal versus output-based drain removal, assessing the following end-points: Clinical : risk of seroma and infection, woundhealing, duration of wound care and drain output versus volume of seroma. Quality of life : drain-induced pain, discomfort due to seroma or drain, sleep disturbance and implications on daily activities. Cost-effectiveness

Recruitment information / eligibility
Status Completed
Enrollment 106
Est. completion date June 30, 2016
Est. primary completion date April 30, 2016
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Patient scheduled for breast cancer surgery with placement of suction drainage - Female or male - Age > 18 years - All stages of disease (inclusion is independent of TNM-classification) Exclusion Criteria: - Patients scheduled for breast cancer surgery without placement of suction drains - No informed consent: Patient refuses participation OR is not able to give a written informed consent

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Early-drain removal
Drain removal at hospital discharge

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Universitaire Ziekenhuizen KU Leuven

Outcome
Type Measure Description Time frame Safety issue
Primary Quality of Life Improve the quality of life, wich will be measured by a questionnaire with some specific questions. 3 weeks
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