Trials / Completed
CompletedNCT03481140
Case Series Comparing Drains to TissuGlu® in a Donor Site DIEP Flap Breast Reconstruction Procedure
Post-Market, Investigator Initiated, Retrospective, Audited Observational Case Series Comparing SWC With Drains to SWC With TissuGlu® and no Drains in a Donor Site DIEP Flap Breast Reconstruction Procedure in 58 Patients
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 58 (actual)
- Sponsor
- Cohera Medical, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | TissuGlu Surgical Adhesive | lysine-derived urethane adhesive |
Timeline
- Start date
- 2015-04-21
- Primary completion
- 2017-11-30
- Completion
- 2017-11-30
- First posted
- 2018-03-29
- Last updated
- 2018-03-29
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03481140. Inclusion in this directory is not an endorsement.