Cancer, Breast
Conditions
Brief summary
Comparing standard wound closure technique with drains (control) to standard wound closure techniques with TissuGlu® and no drains (test) in mastectomy
Detailed description
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.
Interventions
DEVICETest - 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.
Sponsors
Cohera Medical, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Post-Operative Clinical Interventions | from day 0 to day 90 | 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 |
Secondary
| Measure | 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 |
| Patient Benefit Questionnaire | 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 |
| Cumulative days of treatment (with drains or aspiration) | Day 1, 5, 14, 30, 90 |
Countries
Germany, United Kingdom
Outcome results
None listed