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

Not Applicable

Completed

• Conditions: Draining Wound; Breast Cancer
• Interventions: Procedure: Early-drain removal

• Registration Number: NCT03104153
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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

Detailed Description

Not available

Study Timeline

• Study Start: 2015-09
• Primary Completion: 2016-04-30
• Study Completion: 2016-06-30
• Status Verified: 2017-03
• Study First Submitted: 2017-03-27
• Study First Submitted QC: 2017-03-31
• Study First Posted: 2017-04-07
• Last Update Submitted: 2023-11-28
• Last Update Posted: 2023-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 106

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Early-removal	Early-drain removal	-

Primary Outcome Measures

Name	Time	Method
Quality of Life	3 weeks	Improve the quality of life, wich will be measured by a questionnaire with some specific questions.