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

March 28, 2018 updated by: Cohera Medical, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
77

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Post-Operative Clinical Interventions
Time Frame: 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
from day 0 to day 90

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Wound healing related complications
Time Frame: Day 1, 5, 14, 30, 90
Day 1, 5, 14, 30, 90
Cumulative drain volume, aspiration volume, and total wound drainage (drain volume + aspiration volume)
Time Frame: Day 1, 5, 14, 30, 90
Day 1, 5, 14, 30, 90
Days to drain removal
Time Frame: Day 1, 5, 14, 30, 90
Day 1, 5, 14, 30, 90
Cumulative days of treatment (with drains or aspiration)
Time Frame: Day 1, 5, 14, 30, 90
Day 1, 5, 14, 30, 90
Days to discharge from hospital
Time Frame: Day 1, 5, 14, 30, 90
Day 1, 5, 14, 30, 90
Number of Clinically Relevant Seromas formation (number and aspiration volume)
Time Frame: Day 1, 5, 14, 30, 90
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)
Time Frame: Day 1, 5, 14, 30, 90
Day 1, 5, 14, 30, 90
Patient Benefit Questionnaire
Time Frame: Day 1, 5, 14, 30, 90
Day 1, 5, 14, 30, 90

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cohera Medical, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 1, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 3, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 29, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 28, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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