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

Cancer, Breast Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02958449
• Other study ID #: PRO-100-0145
• Status: Completed
• Phase: N/A
• First received: November 3, 2016
• Last updated: March 28, 2018
• Start date: December 2016
• Est. completion date: February 2018

Study information

• Verified date: March 2018
• Source: Cohera Medical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• Cancer, Breast

Intervention

Device:
• 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.

Locations

Country	Name	City	State
Germany	University Hospital Cologne Holweide	Cologne
Germany	University Hospital Cologne St. Elisabeth	Cologne
Germany	University Hospital Erlangen	Erlangen
Germany	University Hospital Greifswald	Greifswald
United Kingdom	Royal Cornwall Hospital	Cornwall
United Kingdom	Derby Teaching Hospitals NHS Foundation Trust	Derby
United Kingdom	University Hospitals of Leicester NHS Foundation Trust	Leicester
United Kingdom	Nottingham University Hospitals NHS Trust	Nottingham
United Kingdom	Royal Hallamshire Hospital	Sheffield
United Kingdom	St. Helens & Knowsley Teaching Hospitals NHS Trust	St Helens

Sponsors (1)

Lead Sponsor	Collaborator
Cohera Medical, Inc.

Countries where clinical trial is conducted

Germany,  United Kingdom, 

Outcome

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