To study the effect of flap fixation on seroma formation in patients undergoing modified radical mastectomy a randomized controlled trial

Breast cancer is the most common cancer and is the leading cause of cancer related death among women worldwide. According to the World Health Organization, the estimated number of newly diagnosed breast cancer cases worldwide was 2,26,1419 in 2020.1 Breast cancer has ranked number one cancer among Indian females with age adjusted rate as high as 25.8 per 100,000 women and mortality 12.7 per 100,000 women.2

Treatment options include surgery, chemotherapy, immunotherapy, radiation therapy, hormonal therapy, and targeted therapy. The most common type of breast surgery is either modified radical mastectomy (MRM) or breast conservative surgery (BCS) with axillary dissection. Mastectomy remains the common surgical treatment. Seroma is the most common complication following breast cancer surgery (15-85%)3 which is defined as accumulation of fluid in the dead space. Seroma forms secondary to accumulation of lymphatic fluid due to damage of lymphatic vessels after axillary dissection. Fluid collection usually occurs between pectoralis muscle and skin flap. It can also cause pain, discomfort, delays wound healing and increases the risk of infection which further increases the hospital stay and delays the start of adjuvant treatment.

Exact pathophysiology of seroma formation is not known. Several factors are held responsible for seroma formation which includes the type of surgery and extent of lymph node dissection. Type of surgical instrument used in the surgery also affects the seroma formation as use of electrocautery increases the incidence of seroma formation.4 However, various predictors have been anticipated which may contribute to seroma formation like age, high body mass index, breast volume, diabetes, hypertension, radiation, neoadjuvant chemotherapy, lymph node involvement by the tumor and the number of lymph nodes dissected during surgery.

To obliterate the dead space after surgery various mechanical and chemical methods have also been proposed which decreases the seroma formation subsequently. Ways to prevent seroma formation includes 1) external compression, 2) flap fixation, 3) use of tissue glues/ tranexamic acid 4) quilting or 5) use of closed suction wound drainage.5 Drains keep the wound dry and help flaps to stick to the chest wall. However, there are several disadvantages of prolonged drainage such as continuous discomfort to the patient, accidental slippage of drain, infection because of retrograde migration of bacteria, prolonged hospitalization or frequent visits to the hospital.

Ideal wound closure should minimize seroma formation by holding skin flaps firmly to the chest wall and obliterating the dead space. However, there is no optimal method but one of the widely tested methods is flap fixation. In this, instead of directly closing the flaps and leaving a cavity beneath it, the flaps are first sutured to the underlying pectoralis major muscle to obliterate the dead space. There is a lack of consensus with different groups producing conflicting results about the efficacy of this technique in reducing seroma formation.

Therefore, we aim to study the effect of flap fixation on seroma formation in patients undergoing modified radical mastectomy.