Prospective Clinical Investigation Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques With TissuGlu® and No Drains (Test) in Mastectomy

Cancer, Breast Clinical Trial

Official title: Prospective Clinical Investigation for a Randomized, Controlled, Multicenter Non-inferiority Study Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques With TissuGlu® and No Drains (Test) in Mastectomy

Status Completed

Clinical Trial Summary

Comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy

Clinical Trial Description

A prospective, randomized, controlled, multicenter non-inferiority study comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy. Patients will be enrolled for 90 Days from day of Surgery. It is expected that it will take 6-9 months for the full duration of the study including the 90 day follow up period. ;

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast

• NCT number: NCT02958449
• Study type: Interventional
• Source: Cohera Medical, Inc.
• Status: Completed
• Phase: N/A
• Start date: December 2016
• Completion date: February 2018