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

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

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.

Inclusion Criteria:

1. ≥ 18 years of age;
2. Provide signed and dated informed consent form;
3. Willing to comply with all study procedures, schedules and be available for the follow-up evaluations for the duration of the study;
4. Willing to follow instructions for incision care and follow guidelines related to resumption of daily activities;
5. Agree not to schedule any additional elective surgical procedures that involve an incision until their participation in this study is complete;
6. In good general health in the opinion of the Investigator with no conditions that would significantly impact wound healing as determined by medical history, and review of recent concomitant medications;
7. Requiring a mastectomy (standard, modified, modified radical) with or without sentinel node biopsy;
8. ≤ ASA 3 - American Society of Anesthesiologists Physical Classification System

Exclusion Criteria:

1. Pregnancy or lactation;
2. Known medical condition that results in compromised blood supply to tissues;
3. Known or suspected allergy or sensitivity to any test materials or reagents;
4. Any condition known to affect wound healing, such as collagen vascular disease;
5. Receiving antibiotic therapy for pre-existing condition or infection;
6. Planned immediate breast reconstruction;
7. Concurrent use of fibrin sealants or other internal wound care devices;
8. Unable to understand questions, instructions or the informed consent presentation in the language of the investigators performing the study;
9. Requiring a mastectomy with ALND (as determined at time of surgery);
10. Be participating in any conflicting medical device clinical trial within 30 days of enrollment in this study.