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

  Summary of Research
  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.

  Summary of Results
  This study looked at whether using ARTISS fibrin glue, a surgical sealant applied during abdominal wound closure, could reduce fluid build-up and improve recovery after DIEP or MS-TRAM breast reconstruction. These operations use tissue from the lower abdomen to rebuild a breast after mastectomy, and drains are routinely used to remove excess fluid and reduce the chance of a seroma, which is a pocket of fluid under the skin.

  A total of 136 patients took part (68 in each group). Patients were randomly assigned to receive either the standard closure technique or the same technique with ARTISS fibrin glue added. All patients followed the same recovery programme at St Andrew’s Centre for Plastic Surgery and Burns.

  Drain duration

  The “typical” time the abdominal drain stayed in place was 6 days with ARTISS and 7 days with standard closure. This small difference did not result in a noticeable improvement in recovery.

  Drain fluid volume

  The “typical” amount of fluid collected by the drain was about 330 mL in the ARTISS group and about 360 mL in the standard group. This difference was small and not large enough to change recovery.

  Seroma formation

  Seromas were uncommon, occurring in 6 out of 135 patients (4.4%): At 2 weeks: 1 seroma in the standard group; none in ARTISS. Between 2–6 weeks: 1 in standard, 3 in ARTISS. At 6 weeks: 1 small symptomatic seroma in standard; none in ARTISS. All seromas were minor and were treated successfully with a single needle drainage in clinic.

  Hospital stay

  Most patients stayed in hospital for 6–7 days, and discharge timing was very similar in both groups.

  Pain and recovery
  Pain levels after surgery were generally low and improved steadily. By day 4, most patients no longer needed strong painkillers, and no patient went home on opioid medications. Pain recovery was similar in both groups.

  Postoperative mobility (steps per day)
  Patients wore step counters to measure early mobility after surgery. Mobility increased every day from day 1 to day 7 in both groups. ARTISS patients showed slightly higher step counts from day 3 onwards. By day 7: ARTISS ~2,600 steps vs Standard closure ~2,150 steps.
  Although ARTISS patients showed a modest trend toward greater mobility, this difference was not large enough to be clinically meaningful.

  Complications
  Most complications were minor wound-related issues. A small number of patients required additional surgery for wound problems. One patient had a serious allergic reaction during anaesthesia, but this was not related to ARTISS. There were no deaths.

  Overall Conclusion
  ARTISS fibrin glue was safe, but it:
  - did not shorten drain duration
  - did not reduce drainage volume
  - did not reduce seroma formation
  - did not improve pain, mobility, or discharge timing
  Overall, ARTISS did not offer a clear clinical benefit compared with standard closure.

• 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