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

Study Overview
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Brief Summary
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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.

Official Title
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Reduction of Seroma and Improvement of Quality of Life After Early Drain Removal in Immediate Breast Reconstruction With Tissue Expander. Preliminary Report of a Randomized Controlled Study

Conditions
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Safety Issues, Quality of Life

Intervention / Treatment
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* Procedure: breast drain removal


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: output based group<br>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 | Procedure: breast drain removal<br>* Investigators remove the drains when the suction drain flow was less than 30 ml/day for at least 2 days or at discharge, with no further signs of infection, fluid collection or impaired wound healing (complicated, see below). Ultimately, we removed drains 3 weeks postoperatively (21 days post op) even if the flow was higher than 30 ml/day. However, leakage or severe patient discomfort led to immediate drain removal at any time during postoperative care.<br>|
| Experimental: early-removal group<br>Investigators remove the drains at hospital discharge, 3-4 days after surgery, regardless of the output at that time | Procedure: breast drain removal<br>* Investigators remove the drains when the suction drain flow was less than 30 ml/day for at least 2 days or at discharge, with no further signs of infection, fluid collection or impaired wound healing (complicated, see below). Ultimately, we removed drains 3 weeks postoperatively (21 days post op) even if the flow was higher than 30 ml/day. However, leakage or severe patient discomfort led to immediate drain removal at any time during postoperative care.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total fluid volume (ml) | sum of drain volumes and volume of seroma aspirations if needed | 21 days | 
| days with drainage |  | 21 days | 
| days of seroma formation | period that drain or seroma aspiration is needed in days after surgery | 21 days | 
| time until wound healing (days) |  | 21 days | 
| infection (yes or not) | defined as the appearance of local signs/symptoms as erythema, edema, induration, increased pain, and a change in drainage to a purulent nature and fever, confirmed by swabs | 21 days | 
| complicated wound healing (yes or not) | unclosed wound 3 weeks postoperatively | 21 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain (using Visual Analogic Score scale to measure intensity) | The visual analog scale (VAS) is a validated, subjective measure for acute and chronic pain. Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between no pain (0) and worst pain. (10) | 21 days | 
| disturbance in quality of sleep (yes or not) |  | 21 days | 
| limitation in personal care, daily activities and social life (yes or not) |  | 21 days | 
| disturbance in mobility (yes or not) | mobility as walking, running, driving | 21 days |