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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| output based group | Active Comparator | 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 |
|
| early-removal group | Experimental | Investigators remove the drains at hospital discharge, 3-4 days after surgery, regardless of the output at that time |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| breast drain removal | Procedure | 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. |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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|
| 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 |