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

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

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

Study Overview

• Status: Completed
• Conditions: Cancer, Breast
• Intervention / Treatment: Device: Test - Standard Closure with TissuGlu Surgical Adhesive

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.

• Study Type: Interventional
• Enrollment (Actual): 77
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test - Standard Closure with TissuGlu Surgical Adhesive; Standard closure plus treatment with TissuGlu	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.
No Intervention: Control - Standard Closure; Standard closure with no intervention

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Cohera Medical, Inc.

Study record dates

Study Major Dates

• Study Start: December 1, 2016
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: November 3, 2016
• First Submitted That Met QC Criteria: November 7, 2016
• First Posted (Estimate): November 8, 2016

Study Record Updates

• Last Update Posted (Actual): March 29, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PRO-100-0145

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes