Status:
COMPLETED
Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure
Lead Sponsor:
Cohera Medical, Inc.
Conditions:
Deep Inferior Epigastric Perforator Flap Reconstruction
Eligibility:
All Genders
18+ years
Brief Summary
To evaluate the safety and effectiveness of a lysine-derived urethane adhesive (TissuGlu® Surgical Adhesive) as a less invasive alternative to surgical drains in the abdominal donor site for deep infe...
Eligibility Criteria
Inclusion
- be 18 years of age or older
- be in good general health (with no conditions that would, in the opinion of the surgeon, exclude them from a drain-free donor site approach)
- have a body mass index (BMI) \< 28
- have received a DIEP flap breast reconstruction procedure
Exclusion
- current smoker
- have a body mass index (BMI) \> 28
- taking active SSRI medication prescriptions
Key Trial Info
Start Date :
April 21 2015
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
November 30 2017
Estimated Enrollment :
58 Patients enrolled
Trial Details
Trial ID
NCT03481140
Start Date
April 21 2015
End Date
November 30 2017
Last Update
March 29 2018
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