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

Universitaire Ziekenhuizen KU Leuven

Status: Completed

Conditions: Breast Cancer; Draining Wound

Treatments: Procedure: Early-drain removal

Study type: Interventional

Funder types: Other

Identifiers

NCT03104153

S58129

Details and patient eligibility

About

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

Enrollment: 106 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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106 participants in 2 patient groups

Output-based

No Intervention group

Early-removal

Active Comparator group

Treatment:

Procedure: Early-drain removal