ARTISS a Single-centre Randomised Control Study (ARTISS)

March 12, 2024 updated by: Mid and South Essex NHS Foundation Trust

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

135

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Essex
      • Broomfield, Essex, United Kingdom, CM1 7ET
        • Mid and South Essex NHS Foundation Trust

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: without ARTISS
Surgery performed without active comparative
Other: no ARTISS
Wound closed without sealant
Active Comparator: with ARTISS
Surgery performed with active comparative
Drug: ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)
Wound sealant

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
post-operative abdominal mean drainage duration
Time Frame: 42 days
post-operative abdominal mean drainage duration
42 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mid and South Essex NHS Foundation Trust

Investigators

  • Study Chair: Mary Morgan, MD, Mid and South Essex NHS Foundation Trust

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2022

Primary Completion (Actual)

February 28, 2023

Study Completion (Actual)

February 28, 2023

Study Registration Dates

First Submitted

June 11, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 18, 2021

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 287482
  • 2021-002624-20 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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