ARTISS on post-operative abdominal fluid and seroma formation in DIEP

• Research type

  Research Study

• Full title

  The Influence of Artiss on post-operative abdominal drainage and seroma formation in DIEP/MS-TRAM free flap breast reconstruction patients.

• IRAS ID

  287482

• Contact name

  Mary Morgan

• Contact email

  mary.morgan10@nhs.net

• Sponsor organisation

  Mid and South Essex NHS Foundation Trust

• Eudract number

  2021-002624-20

• Clinicaltrials.gov Identifier

  NCT04931615

• Duration of Study in the UK

  1 years, 7 months, 28 days

• Research summary

  The deep inferior epigastric flap (DIEP) or free muscle-sparing transverse rectus abdominis myocutaneous flap (MS-TRAM) is one of the most common procedures performed worldwide for breast reconstruction after cancer surgery. During this operation, skin and fatty tissue is raised from the patient’s abdominal wall along with its blood supply (Free flap) and transplanted to blood vessels of the chest wall. One of the commonest complications is the abdominal seroma (collection of fluid), with reported incidences varying from 1% - 57%. It is usually self limiting, but occasionally results in significant problems requiring multiple percutaneous drainages or even surgery to remove the collection of fluid.

  This study will be looking at fluid formation in the abdomen after patients having DIEP free flap for breast reconstruction for breast cancer patients using the fibrin glue called ARTISS. This study will be a randomised controlled trial to compare outcomes between two groups with one using ARTISS glue for the abdomen in the abdominal wound bed and the other group standard closure without using the fibrin glue.

  After randomization, patients will either receive standard care or standard care plus the fibrin glue ARTISS. Inclusion or exclusion into/ from the study will not affect the care the patients receive in any shape or form.

  The primary outcomes investigated will be
  -post-operative abdominal drainage duration in days.

  The secondary outcomes will include
  -abdominal drainage volume
  -hospital duration in days
  -pain score
  -opioid use
  -mobility
  -measure overall operation time (mins)
  -rate of wound complications such as; infection, hematoma, skin flap necrosis, wound dehiscence
  -incidence of seromas in clinic and interventions needed

  The purpose of this study to find out if the fibrin glue ARTISS used in the abdomen will reduce the fluid formation and drainage, which then means it would reduce the hospital stay for patients.

• REC name

  East of Scotland Research Ethics Service REC 2

• REC reference

  21/ES/0085

• Date of REC Opinion

  4 Oct 2021

• REC opinion

  Further Information Favourable Opinion