Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection
Primary Purpose
Draining Wound, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Early-drain removal
Sponsored by
About this trial
This is an interventional treatment trial for Draining Wound
Eligibility Criteria
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Output-based
Early-removal
Arm Description
Outcomes
Primary Outcome Measures
Quality of Life
Improve the quality of life, wich will be measured by a questionnaire with some specific questions.
Secondary Outcome Measures
Full Information
NCT ID
NCT03104153
First Posted
March 27, 2017
Last Updated
March 31, 2017
Sponsor
Universitaire Ziekenhuizen KU Leuven
1. Study Identification
Unique Protocol Identification Number
NCT03104153
Brief Title
Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
April 30, 2016 (Actual)
Study Completion Date
June 30, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universitaire Ziekenhuizen KU Leuven
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Draining Wound, Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
106 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Output-based
Arm Type
No Intervention
Arm Title
Early-removal
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Early-drain removal
Intervention Description
Drain removal at hospital discharge
Primary Outcome Measure Information:
Title
Quality of Life
Description
Improve the quality of life, wich will be measured by a questionnaire with some specific questions.
Time Frame
3 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Early Removal of Wound Drains After Mastectomy or Lymph Node Dissection
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