NCT04931615

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Mid and South Essex NHS Foundation Trust · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Neoplasms
• Mammaplasty

Interventions

Type	Name	Description
DRUG	ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)	Wound sealant
OTHER	no ARTISS	Wound closed without sealant

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-02-28
• Completion: 2023-02-28
• First posted: 2021-06-18
• Last updated: 2024-03-13

Locations

1 site across 1 country: United Kingdom