The effect of a fibrin sealant (ARTISS) to analyze the formation of serous fluid at the back, after harvesting a latissimus dorsi musle to reconstruct a breast.

Phase 1

• Conditions: The aim of this study is to investigate the effect of the fibrin sealant ARTISS compared with our standard care on total volume of donor site seroma after harvesting a LD in immediate breast reconstruction.Our secondary outcomes are drainage volume and duration of drainage, length of hospital stay of a patient, other postoperative complications besides donor site seroma (such as infection), pain measured by the Visual Analog Scale (VAS), and costs in euros.; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2014-000727-25-NL
• Lead Sponsor: Isala Klinieken

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-03-28
• Last Update Posted: 24 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: Not specified

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified