Introduction

The American Society of Plastic Surgeons (ASPS) reported 101,657 breast reconstructions in 2018, nationwide, of which 69,921 with expander/implant position.¹ 
Seroma is the collection of serous fluid in dead space beneath a wound that may need aspiration. It is one of the most common complications following breast reconstruction with an expander, coming in at an incidence that varies between 0.2% and 20%.²
Several factors are implicated: large and irregular dead space after mastectomy, insertion of a foreign body (expander, prosthesis, and ADM), the extent of lymph node dissection, obesity, movement of the chest wall, and adjuvant radiotherapy (RT).²
However, the pathophysiology continues to be debatable: seroma is a mixture of a collection of lymph and acute inflammatory exudate. In breast reconstruction, there are three etiologic factors for local inflammation that can lead to seroma: 1) Surgical trauma (non-viable tissue, lymphatic disruption, and electrocautery damage); 2) A local “hypovascular” state; and 3) Foreign body reaction (tissue expander/ADM).³⁻⁵
Seroma can lead to complications such as infection, delayed wound healing, dehiscence, a prolonged hospital stay, loss of the implant, a need for secondary surgery, and delayed adjuvant therapy, with a consequent increase in global costs. ³, ⁶, ⁷⁻¹¹
There are only a few studies that evaluate the potential risk and cost of complications in breast reconstruction.
In a study of Gabriel et al., there was hypothesized a mean cost for complication of $10,402. ¹² This value was confirmed also by Smith et al.¹³ Same results are described by Damen that estimated about €12,400 the costs for short-term complications of tissue expander breast reconstruction. ¹⁴ Tran et al. in a literature review calculated the cost of possible complications; in particular for aspiration of seroma, they calculated a cost of $370.87. ¹⁵ So, the expected cost (probability of complication ∗ actual cost) of seroma was calculated in $846.24. Incorporating global complication data (seroma, skin necrosis, IV antibiotics, and implant removal) from published literature resulted in the excess cost of about $14,000 (increase of 5% from the cost of a successful reconstruction).¹⁵
In breast reconstruction with tissue expanders, about 80–90% of plastic surgeons routinely put in closed-suction drainage to avoid postoperative hematoma or seroma. ⁶,¹⁶
Drain removal policies vary widely across Breast Cancer Centers.
In today’s literature, most studies report drain removal when volumes are < 20–50 ml/24 h, although this policy necessitates patients going home with drains or undergoing long hospital stays. ²,¹⁶⁻²⁵
However, drain permanence is associated with healthcare costs, discomfort for patients, and daily home nursing.²⁶ 
In fact, most studies report that the patients with drains tend to have longer lengths of hospital stay with higher cost. Reducing drain use decreases costs and outpatient attendances; this strategy does not prolong the time for seroma resolution and it is tolerable for the patients. ²⁷⁻³⁰
Therefore, the goal of our randomized controlled trial was to compare early drain removal with output-based drain removal in patients who underwent mastectomy and immediate reconstruction with a tissue expander. Our experimental hypothesis was to demonstrate that early drain removal is a safe procedure that improves clinical outcomes and QoL. The mechanism of action underlying our proposed approach was threefold, given that early drain removal makes it possible to: 1) Avoid continuous seroma development caused by active drain suction (stopping the circle of “the drain itself potentially perpetuating drainage”); 2) Reduce the risks associated with a “foreign body reaction” through tissue inflammation and infection; and 3) Improve QoL by reducing pain, the length of hospital stay, and limitations on daily activities.