Reduction of Seroma and Improvement of QoL in Breast Reconstruction With Tissue Expander

University of Foggia

Status: Completed

Conditions: Quality of Life; Safety Issues

Treatments: Procedure: breast drain removal

Study type: Interventional

Funder types: Other

Identifiers

NCT04188821

01/2019

Details and patient eligibility

About

The experimental hypothesis of this randomized controlled study was to demonstrate that early drain removal in patients who underwent immediate breast reconstruction with tissue expander is a safety procedure to improving clinical outcomes and quality of life (QoL). The mechanism of action underlying the proposed approach was intuitive. The early drain removal allows to: 1) avoid continuous seroma development caused by active suction of drain (stopping the circle "drain itself may perpetuate the drainage" with vacuum mechanism); 2) reduce the risks connected to "foreign body reaction" as tissue inflammation and infection; 3) improve QoL reducing pain, length of hospital stay and limitations of daily activities.

Enrollment: 124 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• SNS (skin nipple sparing) or SS (skin sparing) mastectomy for breast cancer and immediate positioning of breast expander (without mesh) with placement of suction drain, regardless of TNM classification

Exclusion criteria

• skin reducing mastectomy, reconstruction with flap, direct to implant reconstruction (with or without mesh or ADM) and axillary dissection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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124 participants in 2 patient groups

output based group

Active Comparator group

Description:

Investigators remove the drains when the suction drain flow was less than 30 ml/day for at least 2 days with no further signs of infection, fluid collection or impaired wound healing

Treatment:

Procedure: breast drain removal

early-removal group

Experimental group

Description:

Investigators remove the drains at hospital discharge, 3-4 days after surgery, regardless of the output at that time

Treatment:

Procedure: breast drain removal