ARTISS a Single-centre Randomised Control Study

Mid and South Essex NHS Foundation Trust

Status and phase: Completed; Phase 4

Conditions: Mammaplasty; Breast Neoplasms

Treatments: Drug: ARTISS 4mL Fibrin Sealant Topical Solution (Frozen); Other: no ARTISS

Study type: Interventional

Funder types: Other

Identifiers

NCT04931615

287482

2021-002624-20 (EudraCT Number)

Details and patient eligibility

About

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

Full description

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.

Enrollment: 135 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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135 participants in 2 patient groups, including a placebo group

without ARTISS

Placebo Comparator group

Description:

Surgery performed without active comparative

Treatment:

Other: no ARTISS

with ARTISS

Active Comparator group

Description:

Surgery performed with active comparative

Treatment:

Drug: ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)