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

NCT ID: NCT03104153

Last Updated: 2023-11-29

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

COMPLETED

Clinical Phase

NA

Total Enrollment

106 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-30

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Draining Wound Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Output-based

Group Type NO_INTERVENTION

No interventions assigned to this group

Early-removal

Group Type ACTIVE_COMPARATOR

Early-drain removal

Intervention Type PROCEDURE

Drain removal at hospital discharge

Interventions

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Early-drain removal

Drain removal at hospital discharge

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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S58129

Identifier Type: -

Identifier Source: org_study_id