ARTISS a Single-centre Randomised Control Study

The Influence of ARTISS on Post-operative Abdominal Drainage and Seroma Formation in DIEP/MS-TRAM Free Flap Breast Reconstruction Patients

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04931615

Acronym

ARTISS

Enrollment

135

Registered

2021-06-18

Start date

2022-02-01

Completion date

2023-02-28

Last updated

2024-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms, Mammaplasty

Keywords

muscle-sparing transverse rectus abdominis myocutaneous flap, Deep Inferior Epigastric Artery Perforator

Brief summary

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

Detailed 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.

Interventions

DRUGARTISS 4mL Fibrin Sealant Topical Solution (Frozen)

Wound sealant

OTHERno ARTISS

Wound closed without sealant

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Outcomes Assessor)

Masking description

Blinded patient and blinded assessor

Intervention model description

Randomised controlled trial

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 80 Years

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

Design outcomes

Primary

Measure	Time frame	Description
post-operative abdominal mean drainage duration	42 days	post-operative abdominal mean drainage duration

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026