ARTISS a Single-centre Randomised Control Study

Breast Neoplasms Clinical Trial

— ARTISS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04931615
• Other study ID #: 287482
• Secondary ID: 2021-002624-20
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2022
• Est. completion date: February 28, 2023

Study information

• Verified date: October 2023
• Source: Mid and South Essex NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: February 28, 2023
• Est. primary completion date: February 28, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Neoplasms
• Mammaplasty

Intervention

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

Other:
• no ARTISS
Wound closed without sealant

Locations

Country	Name	City	State
United Kingdom	Mid and South Essex NHS Foundation Trust	Broomfield	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Mid and South Essex NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	post-operative abdominal mean drainage duration	post-operative abdominal mean drainage duration	42 days