Drain-Less Abdominally Based Breast Reconstruction Using Lysine-Derived Urethane Adhesive

November 20, 2020 updated by: Case Comprehensive Cancer Center

Drain-Less Abdominally Based Breast Reconstruction Using a Novel Lysine-Derived Urethane Adhesive (TissueGlu, Cohera Medical)

Drains are routinely utilized in breast reconstruction when using abdominal tissue of the patient to remove fluid buildup while the body heals after surgery. However, drains are associated with patient discomfort, anxiety, decreased mobility, increased hospital stays and outpatient visits. Drains can also serve as a site of origin for infection as the system is not completely closed, and infectious organisms could theoretically use the drain as point of entry.

This proposed study investigates a potential novel mechanism to prevent the development of seromas (pockets of clear fluid which can develop after surgery) in patients who undergo breast reconstruction with their own abdominal tissue. By eliminating the required use of a drain, the study team expects patients to have less pain and use less pain medication, as well as more satisfaction with their overall surgical experience.

Study Overview

Status

Status

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Withdrawn

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

Objectives:

  1. Establish the safety of a lysine-derived urethane adhesive (TissuGlu, Cohera Medical) in patients undergoing autologous abdominal-based breast reconstruction. This will be assessed via analyzing complication profiles of patients post-operatively. The primary endpoints are rate of seroma development, need for seroma drainage and time to drain removal (if in drain group).
  2. Determine if there is a difference in pain and other quality of life measures when comparing patients who do and do not have abdominal drains. This will be assessed via pain medicine utilization and by delivering a targeted survey pre-operatively, as well as at post-operative day three and four weeks.

Study Design:

Patients will be randomized to one of three arms: 1) Traditional closed-suction drains, 2) TissuGlu with closed-suction drains and 3) TissuGlu without closed-suction drains.

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

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

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

22 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing Abdominally-Based Breast Reconstruction

    • Both unilateral or bilateral reconstruction is allowed
  • Both delayed or immediate reconstruction is allowed

Exclusion Criteria:

  • Diabetes
  • BMI>30
  • Active smokers.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

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.
Active Comparator: Tissue Glu with drains
This is standard of care to use Tissue Glu in addition to a drain. Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities. Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal
Device: Tissue Glu
Once adequate hemostasis has been achieved during surgery and the abdominal fascia and flaps have been irrigated, Tissue Glu will be applied. Tissue Glu is applied at approximately one centimeter intervals while remaining one centimeter away from the umbilicus and inferior incisions.
Other Names:
  • TissuGlu
  • lysine-derived urethane adhesive
Device: Drain
Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery
Other Names:
  • closed-suction drains
Other: Questionnaires
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers
Experimental: Tissue Glu without drains
This group utilizes Tissue Glu without the presence of a drain. Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities. Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal
Device: Tissue Glu
Once adequate hemostasis has been achieved during surgery and the abdominal fascia and flaps have been irrigated, Tissue Glu will be applied. Tissue Glu is applied at approximately one centimeter intervals while remaining one centimeter away from the umbilicus and inferior incisions.
Other Names:
  • TissuGlu
  • lysine-derived urethane adhesive
Other: Questionnaires
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers
Active Comparator: Drains
This is standard of care to use traditional closed-suction drains. Pre-operatively, as well as on post-operative patients will be asked to complete a questionnaire that addresses their pain, impact of drains on activities of daily living, social and physical activities. Patients will also be asked to provide information regarding who is caring for the drains, the impact of drains on the caregiver, the amount of anxiety the patient has related to drain removal and the amount of pain associated with drain removal
Device: Drain
Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery
Other Names:
  • closed-suction drains
Other: Questionnaires
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers

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
Rate of seroma development
Time Frame: Up to 30 days after surgery
Number of seromas which develop during the first 30 days after surgery.
Up to 30 days after surgery

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
Measure Description
Time Frame
Difference in pain between patients with and without abdominal drains
Time Frame: Up to 4 weeks after surgery
Patients will be given a questionnaire pre-operatively and the same questionnaire post-operatively. The change in these questionnaires will be compared between groups
Up to 4 weeks after surgery
Pain Medicine Utilization
Time Frame: Up to 4 weeks after surgery
Use of pain medicine after surgery between groups, as indicated by chart review
Up to 4 weeks after surgery
Time to drain removal
Time Frame: Up to 4 weeks after surgery
Time from surgery to the removal of the drain for any reason, in patients who were given a drain
Up to 4 weeks after surgery

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.
Case Comprehensive Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Andrea Moreira, MD, Cleveland Clinic, Case Comprehensive Cancer Center

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 (Anticipated)

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.
November 1, 2020

Primary Completion (Anticipated)

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, 2021

Study Completion (Anticipated)

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.
September 1, 2021

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).
May 17, 2017

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.
May 17, 2017

First Posted (Actual)

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.
May 18, 2017

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.
November 24, 2020

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.
November 20, 2020

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.
November 1, 2020

More Information

Terms related to this study

Keywords

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.
  • CASE5117

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.

No

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.

Clinical Trials on Breast Cancer

Clinical Trials on Tissue Glu

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings