Clinical Trial: Investigating the Use of Drains and (Internal) Quilting Sutures on Seroma Formation Following Mastectomy

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary: Seroma formation is a common complication following breast and axillary surgery for breast cancer. The use of drains is commonplace in practice after mastectomy, although there is evidence to suggest that they do not affect the incidence of symptomatic seroma formation. Methods have been adopted in attempts to decrease seroma formation, to varying results, which include the use of deep sutures. The aim of this study is to evaluate the effect of drains and quilting sutures on the incidence of seroma formation. Patients undergoing mastectomy and axillary surgery for breast cancer will be eligible. Patients will be randomized to either receive a drain, no drain or no drain with quilting sutures. The primary outcome measure will be the incidence of symptomatic seroma. Secondary outcome measures will be postoperative length of stay and postoperative pain scores.

Detailed Summary:

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 nat
Sponsor: North Tees and Hartlepool NHS Foundation Trust

Current Primary Outcome: Seroma formation [ Time Frame: One week post-operatively ]

Incidence of symptomatic seroma post-operatively. A seroma defined as a palpable fluid collection under the wound.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Seroma aspiration [ Time Frame: up to 1 month ]
    Any symptomatic seromas will be aspirated, and the volume in milliliters will be recorded.
  • Pain scores [ Time Frame: up to 2 days post-operatively ]
    Daily Post-operative pain scores using visual analogue scale
  • Length of Stay [ Time Frame: up to 1 week ]
    Postoperative length of stay in days


Original Secondary Outcome: Same as current

Information By: North Tees and Hartlepool NHS Foundation Trust

Dates:
Date Received: January 18, 2016
Date Started: November 2015
Date Completion: November 2016
Last Updated: January 28, 2016
Last Verified: January 2016