ARTISS a Single-centre Randomised Control Study

Mid and South Essex NHS Foundation Trust135 enrolled

Overview

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

The principle aim of the study is to investigate the effect of ARTISS on abdominal wound drainage whether this could result in earlier drain removal and earlier patient discharge from hospital. The primary outcome investigated will be post- operative abdominal drainage duration in days which is vital information during this Covid pandemic to reduce hospital stay (and therefore possible Covid exposure) which could result in earlier discharge from hospital, as well as significantly reducing cost of the procedure to the NHS and frees in-patient beds for more efficient use of resources.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

135

Conditions

Breast Neoplasms Mammaplasty

Interventions

ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)DRUG

Wound sealant

no ARTISSOTHER

Wound closed without sealant

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Female adult (age 18-80) * Patients planned for immediate or delayed DIEP/MS-TRAM breast reconstruction Exclusion Criteria: * Patients who are unable to consent or do not consent * Clotting disorder * Pregnancy * Individuals whose immune system is depressed or who have some types of anaemia (e.g. sickle cell disease or haemolytic anaemia). * COVID positive * Known previous allergic reactions to ARTISS

Locations (1)

Mid and South Essex NHS Foundation Trust

Broomfield, Essex, United Kingdom

Outcomes

Primary Outcomes

post-operative abdominal mean drainage duration

Time frame: 42 days

Data from ClinicalTrials.gov

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