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ARTISS trial

Full title: The Influence of ARTISS on post-operative abdominal drainage and seroma formation in DIEP/MS-TRAM free flap breast reconstruction patients

The ARTISS trial is a randomised controlled trial at St. Andrew’s Centre for Plastic Surgery and Burns (Mid and South Essex NHS Foundation Trust (MSEFT)) comparing standard closure of the abdominal wound during breast reconstruction surgery, with or without the addition of a tissue sealant (ARTISS), on post-surgery fluid drainage duration.

View of two surgeons at work in the operating theatre, from over the shoulder of a third

The most common surgeries undertaken worldwide for breast reconstruction after breast cancer are known as DIEP and MS-TRAM. Skin and fatty tissue are taken from the lower stomach (abdominal wall) with the blood supply and then transplanted to blood vessels of the chest wall under the breast.

One of the most common complications from this surgery is a seroma in the stomach. A seroma is a local collection of clear fluid that sometimes occurs in a part of the body where the tissue has been cut and removed during surgery. This fluid may cause swelling and discomfort as it collects under the skin. It normally gets better by itself, but sometimes results in problems and the need to insert drains to release fluid, or even further surgery.

The standard way to close the abdominal wound is with stitches. In addition to closing the wound with stitches, a tissue sealant can be used. Tissue sealants are a type of glue and have been used in many types of surgery. One brand of tissue sealant is called ARTISS, developed by Baxter Healthcare Ltd.

The principal aim of this study is to investigate the effect of ARTISS on abdominal wound drainage, and whether this could result in earlier drain removal.

Trial setting, design, and methods

This is a single-centre trial being conducted at St. Andrew’s Centre for Plastic Surgery and Burns (MSEFT). It is double blinded, parallel, randomised, controlled trial.

The study recruited 138 patients who were planned for breast reconstruction (DIEP/MS-TRAM) surgery and randomly assigned them to either surgery with standard abdominal closure, or standard abdominal closure plus ARTISS.

Trial objectives

To compare outcomes between the two groups of participants: the primary outcome will be post-operative abdominal drainage duration (in days). Secondary outcomes will also be assessed.

Chief Investigator: Miss Mary Morgan (MSEFT)
ARCTU involvement: Trial management; database; randomisation service; statistical service
Trial sponsor and funding: Mid and South Essex NHS Foundation Trust (sponsor); Baxter Healthcare Ltd. (funder)

Project reference numbers: EudraCT: 2021-002624-20; ClincialTrials.gov: NCT04931615