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Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure

NCT03481140 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 58

Last updated 2018-03-29

No results posted yet for this study

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 inferior epigastric perforator (DIEP) flap reconstruction.

Conditions

  • Deep Inferior Epigastric Perforator Flap Reconstruction

Interventions

DEVICE

TissuGlu Surgical Adhesive

lysine-derived urethane adhesive

Sponsors & Collaborators

  • Cohera Medical, Inc.

    lead INDUSTRY

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-04-21
Primary Completion
2017-11-30
Completion
2017-11-30
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03481140 on ClinicalTrials.gov