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

NCT02958449 | Completed DMC FDA Device

• 1 other identifier: PRO-100-0145
• Study Type: interventional
• Target: 77
• Locations: 2 countries
• Sites: 10

Brief Summary

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

Conditions

Cancer, Breast

Outcome Measures

Primary Outcomes (1)

• Number of Post-Operative Clinical Interventions

  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

  from day 0 to day 90

Secondary Outcomes (8)

• 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

Study Arms (2)

Test - Standard Closure with TissuGlu Surgical Adhesive

EXPERIMENTAL

Standard closure plus treatment with TissuGlu

Device: Test - Standard Closure with TissuGlu Surgical Adhesive

Control - Standard Closure

NO INTERVENTION

Standard closure with no intervention

Interventions

Test - Standard Closure with TissuGlu Surgical Adhesive 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.

Test - Standard Closure with TissuGlu Surgical Adhesive

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age;
• Provide signed and dated informed consent form;
• Willing to comply with all study procedures, schedules and be available for the follow-up evaluations for the duration of the study;
• Willing to follow instructions for incision care and follow guidelines related to resumption of daily activities;
• Agree not to schedule any additional elective surgical procedures that involve an incision until their participation in this study is complete;
• 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;
• Requiring a mastectomy (standard, modified, modified radical) with or without sentinel node biopsy;
• ≤ ASA 3 - American Society of Anesthesiologists Physical Classification System

You may not qualify if:

• Pregnancy or lactation;
• Known medical condition that results in compromised blood supply to tissues;
• Known or suspected allergy or sensitivity to any test materials or reagents;
• Any condition known to affect wound healing, such as collagen vascular disease;
• Receiving antibiotic therapy for pre-existing condition or infection;
• Planned immediate breast reconstruction;
• Concurrent use of fibrin sealants or other internal wound care devices;
• Unable to understand questions, instructions or the informed consent presentation in the language of the investigators performing the study;
• Requiring a mastectomy with ALND (as determined at time of surgery);
• Be participating in any conflicting medical device clinical trial within 30 days of enrollment in this study.

Sponsors & Collaborators

• Cohera Medical, Inc.: lead

Study Sites (10)

University Hospital Cologne Holweide

Cologne, Germany

Location

University Hospital Cologne St. Elisabeth

Cologne, Germany

Location

University Hospital Erlangen

Erlangen, Germany

Location

University Hospital Greifswald

Greifswald, Germany

Location

Royal Cornwall Hospital

Cornwall, United Kingdom

Location

Derby Teaching Hospitals NHS Foundation Trust

Derby, United Kingdom

Location

University Hospitals of Leicester NHS Foundation Trust

Leicester, United Kingdom

Location

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

Royal Hallamshire Hospital

Sheffield, United Kingdom

Location

St. Helens & Knowsley Teaching Hospitals NHS Trust

St Helens, United Kingdom

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2016
• First Posted: November 8, 2016
• Study Start: December 1, 2016
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: March 29, 2018

Record last verified: 2018-03

Locations

GB (6); DE (4)