ARTISS a Single-centre Randomised Control Study

Phase 4

Completed

• Conditions: Breast Neoplasms; Mammaplasty
• Interventions: Drug: ARTISS 4mL Fibrin Sealant Topical Solution (Frozen); Other: no ARTISS

• Registration Number: NCT04931615
• Lead Sponsor: Mid and South Essex NHS Foundation Trust

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.

Study Timeline

• Study First Submitted: 2021-06-11
• Study First Submitted QC: 2021-06-16
• Study First Posted: 2021-06-18
• Study Start: 2022-02-01
• Primary Completion: 2023-02-28
• Study Completion: 2023-02-28
• Status Verified: 2023-10
• Last Update Submitted: 2024-03-12
• Last Update Posted: 2024-03-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
with ARTISS	ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)	Surgery performed with active comparative
without ARTISS	no ARTISS	Surgery performed without active comparative

Primary Outcome Measures

Name	Time	Method
post-operative abdominal mean drainage duration	42 days	post-operative abdominal mean drainage duration

Trial Locations

Locations (1)

Mid and South Essex NHS Foundation Trust; 🇬🇧 Broomfield, Essex, United Kingdom