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Completed

NCT Number: 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.

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Key information

Conditions

Breast Neoplasms Breast Diseases Mammaplasty Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Mid and South Essex NHS Foundation Trust

Broomfield, Essex, CM1 7ET, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)

Drug

Wound sealant

no ARTISS

Other

Wound closed without sealant

Primary outcomes

  1. post-operative abdominal mean drainage duration

    Time frame: 42 days

    post-operative abdominal mean drainage duration

Sponsors and collaborators

Lead sponsor

Mid and South Essex NHS Foundation Trust

Other

Registry information

Official study title

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

Acronym: ARTISS

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 18, 2021
Registry last updated
Mar 13, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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