Clinical trial NCT02958449: Prospective Clinical Investigation Comparing Standard Wound Closure Technique With Drains (Control) to Standard Wound Closure Techniques With TissuGlu® and No Drains (Test) in Mastectomy
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer, Breast
Lead sponsor: Cohera Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2016-11-08
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Post-Operative Clinical Interventions
timeFrame: from day 0 to day 90
Secondary outcomes:
measure: Wound healing related complications
timeFrame: Day 1, 5, 14, 30, 90
measure: Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume)
timeFrame: Day 1, 5, 14, 30, 90
measure: Days to drain removal
timeFrame: Day 1, 5, 14, 30, 90
measure: Cumulative days of treatment (with drains or aspiration)
timeFrame: Day 1, 5, 14, 30, 90
measure: Days to discharge from hospital
timeFrame: Day 1, 5, 14, 30, 90
measure: Number of Clinically Relevant Seromas formation (number and aspiration volume)
timeFrame: Day 1, 5, 14, 30, 90
measure: Incidence and timing of initiation of adjuvant therapy related to the mastectomy procedure (such as radiation therapy, chemotherapy, endocrine therapy)
timeFrame: Day 1, 5, 14, 30, 90
measure: Patient Benefit Questionnaire
timeFrame: Day 1, 5, 14, 30, 90
Other outcomes:
Locations:
city: Cologne
country: Germany
facility: University Hospital Cologne Holweide
city: Cologne
country: Germany
facility: University Hospital Cologne St. Elisabeth
city: Erlangen
country: Germany
facility: University Hospital Erlangen
city: Greifswald
country: Germany
facility: University Hospital Greifswald
city: Cornwall
country: United Kingdom
facility: Royal Cornwall Hospital
city: Derby
country: United Kingdom
facility: Derby Teaching Hospitals NHS Foundation Trust
city: Leicester
country: United Kingdom
facility: University Hospitals of Leicester NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Nottingham University Hospitals NHS Trust
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: St Helens
country: United Kingdom
facility: St. Helens & Knowsley Teaching Hospitals NHS Trust
Study officials:
References: