EUCTR2014-000727-25-NL
Active, not recruiting
Phase 1
The effect of ARTISS on latissimus dorsi donor site seroma formation after breast reconstruction: a randomised controlled trial.
Isala Klinieken0 sitesStarted: March 28, 2017Last updated:
DrugsARTISS
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Isala Klinieken
Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •All female patients older than 18 years, who will undergo a breast reconstruction with a LD flap will be included. All participating patients have to sign a written consent, before they can be included in our study.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 118
- •F.1\.3 Elderly (\>\=65 years) no
- •F.1\.3\.1 Number of subjects for this age range
Exclusion Criteria
- •Patients who are pregnant, have a pre\-operative on\-going infection, history of systemic anti\-coagulant use, known hypersensitivity to ARTISS or postoperative haemorrhage will be excluded.
Investigators
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