Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE4
135 participants
INTERVENTIONAL
2022-02-01
2023-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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without ARTISS
Surgery performed without active comparative
no ARTISS
Wound closed without sealant
with ARTISS
Surgery performed with active comparative
ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)
Wound sealant
Interventions
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ARTISS 4mL Fibrin Sealant Topical Solution (Frozen)
Wound sealant
no ARTISS
Wound closed without sealant
Eligibility Criteria
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Inclusion Criteria
* Patients planned for immediate or delayed DIEP/MS-TRAM breast reconstruction
Exclusion Criteria
* 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
18 Years
80 Years
FEMALE
No
Sponsors
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Mid and South Essex NHS Foundation Trust
OTHER
Responsible Party
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Principal Investigators
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Mary Morgan, MD
Role: STUDY_CHAIR
Mid and South Essex NHS Foundation Trust
Locations
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Mid and South Essex NHS Foundation Trust
Broomfield, Essex, United Kingdom
Countries
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Other Identifiers
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2021-002624-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
287482
Identifier Type: -
Identifier Source: org_study_id
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