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 Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

77 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2018-02-28

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

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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.

Conditions

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Cancer, Breast

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Test - Standard Closure with TissuGlu Surgical Adhesive

Standard closure plus treatment with TissuGlu

Group Type EXPERIMENTAL

Test - Standard Closure with TissuGlu Surgical Adhesive

Intervention Type DEVICE

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.

Control - Standard Closure

Standard closure with no intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No