Back to resultsARTISS a Single-centre Randomised Control Study (ARTISS)
Primary Purpose
Breast Neoplasms, Mammaplasty
Status
Recruiting
Phase
Phase 4
Locations
United Kingdom
Study Type
Interventional
Intervention
ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)
no ARTISS
Sponsored by
About this trial
This is an interventional treatment trial for Breast Neoplasms focused on measuring muscle-sparing transverse rectus abdominis myocutaneous flap, Deep Inferior Epigastric Artery Perforator
Eligibility Criteria
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
Sites / Locations
- Mid and South Essex NHS Foundation TrustRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
without ARTISS
with ARTISS
Arm Description
Surgery performed without active comparative
Surgery performed with active comparative
Outcomes
Primary Outcome Measures
post-operative abdominal mean drainage duration
post-operative abdominal mean drainage duration
Secondary Outcome Measures
Full Information
NCT ID
NCT04931615
First Posted
June 11, 2021
Last Updated
October 19, 2023
Sponsor
Mid and South Essex NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT04931615
Brief Title
ARTISS a Single-centre Randomised Control Study
Acronym
ARTISS
Official Title
The Influence of ARTISS on Post-operative Abdominal Drainage and Seroma Formation in DIEP/MS-TRAM Free Flap Breast Reconstruction Patients
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
January 1, 2024 (Anticipated)
Study Completion Date
January 1, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mid and South Essex NHS Foundation Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms, Mammaplasty
Keywords
muscle-sparing transverse rectus abdominis myocutaneous flap, Deep Inferior Epigastric Artery Perforator
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
ParticipantOutcomes Assessor
Masking Description
Blinded patient and blinded assessor
Allocation
Randomized
Enrollment
138 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
without ARTISS
Arm Type
Placebo Comparator
Arm Description
Surgery performed without active comparative
Arm Title
with ARTISS
Arm Type
Active Comparator
Arm Description
Surgery performed with active comparative
Intervention Type
Drug
Intervention Name(s)
ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)
Intervention Description
Wound sealant
Intervention Type
Other
Intervention Name(s)
no ARTISS
Intervention Description
Wound closed without sealant
Primary Outcome Measure Information:
Title
post-operative abdominal mean drainage duration
Description
post-operative abdominal mean drainage duration
Time Frame
42 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Isuruperera Manimeldura, MD
Phone
01245556717
Email
manimelduraisuruperera@nhs.net
First Name & Middle Initial & Last Name or Official Title & Degree
Carol Alves, MRes
Phone
01268394672
Email
carol.alves@nhs.net
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mary Morgan, MD
Organizational Affiliation
Mid and South Essex NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Mid and South Essex NHS Foundation Trust
City
Broomfield
State/Province
Essex
ZIP/Postal Code
CM1 7ET
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Morgan, MD
Phone
01245556717
Email
mary.morgan10@nhs.net
First Name & Middle Initial & Last Name & Degree
Isuruperera Manimeldura, MD
Phone
01245556717
Email
manimelduraisuruperera@nhs.net
12. IPD Sharing Statement
Learn more about this trial
ARTISS a Single-centre Randomised Control Study
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