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

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

Detailed Description
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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.

Official Title
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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

Conditions
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Cancer, Breast

Intervention / Treatment
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* Device: Test - Standard Closure with TissuGlu Surgical Adhesive


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ≥ 18 years of age; Provide signed and dated informed consent form; Willing to comply with all study procedures, schedules and be available for the follow-up evaluations for the duration of the study; Willing to follow instructions for incision care and follow guidelines related to resumption of daily activities; Agree not to schedule any additional elective surgical procedures that involve an incision until their participation in this study is complete; 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; Requiring a mastectomy (standard, modified, modified radical) with or without sentinel node biopsy; ≤ ASA 3 - American Society of Anesthesiologists Physical Classification System Exclusion Criteria: Pregnancy or lactation; Known medical condition that results in compromised blood supply to tissues; Known or suspected allergy or sensitivity to any test materials or reagents; Any condition known to affect wound healing, such as collagen vascular disease; Receiving antibiotic therapy for pre-existing condition or infection; Planned immediate breast reconstruction; Concurrent use of fibrin sealants or other internal wound care devices; Unable to understand questions, instructions or the informed consent presentation in the language of the investigators performing the study; Requiring a mastectomy with ALND (as determined at time of surgery); Be participating in any conflicting medical device clinical trial within 30 days of enrollment in this study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test - Standard Closure with TissuGlu Surgical Adhesive<br>Standard closure plus treatment with TissuGlu | Device: Test - Standard Closure with TissuGlu Surgical Adhesive<br>* 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.<br>|
| No Intervention: Control - Standard Closure<br>Standard closure with no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Post-Operative Clinical Interventions | Clinical Intervention is defined as one of the following events: Removal of an in-dwelling drain (As defined in the Protocol); Needle aspiration to remove fluid from a Clinically-Relevant Seroma (As defined in the Protocol); Invasive action to the drain or drain wound such as repositioning or re-attaching the drain retention sutures; Reinsertion or insertion of a drain post operatively; Surgical procedures due to wound healing complications related to wound management | from day 0 to day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wound healing related complications |  | Day 1, 5, 14, 30, 90 | 
| Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume) |  | Day 1, 5, 14, 30, 90 | 
| Days to drain removal |  | Day 1, 5, 14, 30, 90 | 
| Cumulative days of treatment (with drains or aspiration) |  | Day 1, 5, 14, 30, 90 | 
| Days to discharge from hospital |  | Day 1, 5, 14, 30, 90 | 
| Number of Clinically Relevant Seromas formation (number and aspiration volume) |  | 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) |  | Day 1, 5, 14, 30, 90 | 
| Patient Benefit Questionnaire |  | Day 1, 5, 14, 30, 90 |