Comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
77
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.
University Hospital Cologne Holweide
Cologne, Germany
University Hospital Cologne St. Elisabeth
Cologne, Germany
University Hospital Erlangen
Erlangen, Germany
University Hospital Greifswald
Number of Post-Operative Clinical Interventions
Clinical Intervention is defined as one of the following events: 1. Removal of an in-dwelling drain (As defined in the Protocol); 2. Needle aspiration to remove fluid from a Clinically-Relevant Seroma (As defined in the Protocol); 3. Invasive action to the drain or drain wound such as repositioning or re-attaching the drain retention sutures; 4. Reinsertion or insertion of a drain post operatively; 5. Surgical procedures due to wound healing complications related to wound management
Time frame: from day 0 to day 90
Wound healing related complications
Time frame: Day 1, 5, 14, 30, 90
Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume)
Time frame: Day 1, 5, 14, 30, 90
Days to drain removal
Time frame: Day 1, 5, 14, 30, 90
Cumulative days of treatment (with drains or aspiration)
Time frame: Day 1, 5, 14, 30, 90
Days to discharge from hospital
Time frame: Day 1, 5, 14, 30, 90
Number of Clinically Relevant Seromas formation (number and aspiration volume)
Time frame: Day 1, 5, 14, 30, 90
Incidence and timing of initiation of adjuvant therapy related to the mastectomy procedure (such as radiation therapy, chemotherapy, endocrine therapy)
Time frame: Day 1, 5, 14, 30, 90
Patient Benefit Questionnaire
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Greifswald, Germany
Royal Cornwall Hospital
Cornwall, United Kingdom
Derby Teaching Hospitals NHS Foundation Trust
Derby, United Kingdom
University Hospitals of Leicester NHS Foundation Trust
Leicester, United Kingdom
Nottingham University Hospitals NHS Trust
Nottingham, United Kingdom
Royal Hallamshire Hospital
Sheffield, United Kingdom
St. Helens & Knowsley Teaching Hospitals NHS Trust
St Helens, United Kingdom
Time frame: Day 1, 5, 14, 30, 90