Clinical trial investigating seromas following mastectomy

• Research type

  Research Study

• Full title

  Randomised clinical trial investigating the use of drains and quilting sutures on seroma formation following mastectomy

• IRAS ID

  109096

• Contact name

  P Bhaskar

• Contact email

  pud.bhaskar@nth.nhs.uk

• Sponsor organisation

  North Tees and Hartlepool NHS Trust

• Research summary

  Breast cancer affects around 46,000 patients a year. The mainstay of treatment involves surgery to the breast and axilla (armpit region). Sometimes the whole breast is removed, called a mastectomy. The most common postoperative complication is a fluid collection underneath the wound (seroma). Despite being considered a minor complication, it may be the cause of considerable discomfort if the quantity of fluid accumulated is large enough. This is usually upwards of 100mls. Occasionally, seromas need draining, usually using a needle puncture through the skin and syringe. Many surgeons use a drain following surgery for cancer to deal with this, although there is no clear evidence to suggest that a drain significantly reduces seroma formation. Drains have been found to increase the post-operative stay of patients, as well as causing discomfort themselves.
  Other methods other than drains exist in attempting to reduce post-operative seroma formation. These include the use of sutures which aim to reduce the free space under the wound in which fluid can accumulate
  The aim is to perform a pilot study to compare the incidence of symptomatic seroma following mastectomy for breast cancer between patients managed with a drain, patients managed without a drain and patients managed without a drain but with internal sutures, called 'quilting' sutures. Patients will be randomised into any of the three groups. Patients and Breast Care Nurses will be blinded to the group if they do NOT receive a drain but will obviously be aware if they do.

• REC name

  North East - Newcastle & North Tyneside 2 Research Ethics Committee

• REC reference

  14/NE/0091

• Date of REC Opinion

  6 Jun 2014

• REC opinion

  Further Information Favourable Opinion