Randomised Clinical Trial Investigating the Use of Drains and Quilting Sutures on Seroma Formation Following Mastectomy - A Pilot Study

Background: The mainstay of treatment for the majority of breast cancers is surgical excision of the primary tumour either by removing the lump (wide local excision) or the whole breast, mastectomy. Breast cancer can commonly spread to the lymph nodes in the armpit (axilla) meaning surgery to remove the cancer also involves surgery to axilla to sample lymph nodes. The most common complication following mastectomy is a fluid collection deep to the wound called a seroma. This is generally a minor complication but may cause significant discomfort / distress to the patient. If the seroma is of a significant size as to cause discomfort, it is usually drained using a needle and syringe near the wound. This is not only to improve patient discomfort, but seromas can lead to wound healing problems which may delay the onset of adjuvant treatment, such as radio- or chemotherapy. The incidence of seroma is variable, but the most commonly quoted incidence of seroma formation is between 15% and 27%.

In a bid to reduce seroma formation, surgeons use drains following mastectomy to theoretically remove any excess fluid that may accumulate following surgery. This is the current practice in our unit at North Tees. Despite the widespread use of drains following mastectomy, there is no clear evidence to suggest that the use of drains significantly reduces seroma formation. There are also no consensus guidelines for the use of postoperative drains. Most surgeons advocate the removal of drains when the volume drained is less than 50ml/day. Patients with a drain in-situ may be kept as inpatients until drain removal, others may go home with drains with frequent review at home by the breast care nursing team. As a consequence, drains may contribute to a longer postoperative stay and have also been linked to higher postoperative pain scores.

The nature and behaviour of seromas remains ambiguous; it is hard predicting which patients will be troubled by them. There is one argument however, that seroma fluid may be increased by the presence of a drain. This is because the drain may irritate the tissues underneath the wound, resulting in the tissues producing more fluid which may accumulate into a seroma. Therefore, there lies a theoretical basis for which drains should be avoided altogether.

Other measures have been adopted other than drains in a bid to reduce seroma formation. One of the main ones are the use of 'quilting sutures' deep to the wound. These have previously been used either in addition to a drain or without. Quilting sutures aim to reduce the 'free space' left in the tissues following removal of the breast by adhering the tissues together. The free space, commonly called 'dead space' is a risk factor for the accumulation of fluid. It has been shown in studies that with or without a drain, these sutures (or stitches) reduce the incidence of seroma and reduce the length of inpatient stay.

Aim/Objective: This pilot study aims to determine the effect that drains and quilting sutures have on the incidence of symptomatic seroma formation following mastectomy and axillary surgery for breast cancer. A symptomatic seroma is defined as a fluid collection beneath the mastectomy wound which develops post-operatively, causing tension on the healing wound and discomfort to the patient, thus needing drainage. This is usually approximately 100mls or greater in quantity of fluid.