NCT02958449 - Prospective Clinical Investigation Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques With TissuGlu® and No Drains (Test) in Mastectomy | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

February 28, 2018

Study Completion Date

February 28, 2018

Conditions

Cancer, Breast

Interventions

DEVICE

Test - Standard Closure with TissuGlu Surgical Adhesive

Patients randomized into the Test group, TissuGlu® will be applied to the chest wall after removal of the breast tissue using the custom applicator during a standard mastectomy procedure followed by normal wound closure (suturing technique) without drain placement.

Trial Locations (10)

Unknown

University Hospital Cologne Holweide, Cologne

University Hospital Cologne St. Elisabeth, Cologne

University Hospital Erlangen, Erlangen

University Hospital Greifswald, Greifswald

Royal Cornwall Hospital, Cornwall

Derby Teaching Hospitals NHS Foundation Trust, Derby

University Hospitals of Leicester NHS Foundation Trust, Leicester

Nottingham University Hospitals NHS Trust, Nottingham

Royal Hallamshire Hospital, Sheffield

St. Helens & Knowsley Teaching Hospitals NHS Trust, St Helens