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

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ClinicalTrials.gov Identifier: NCT03159598
Recruitment Status : Withdrawn (PI left institution, never submitted to IRB)
First Posted : May 18, 2017
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Breast Cancer Device: Tissue Glu Device: Drain Other: Questionnaires Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This study has three parallel groups. One experimental and two control groups
Masking: Single (Participant)
Masking Description: The study is "semi-blind" in that patients will not be told which treatment they are receiving. If the patient is assigned to one of the drains groups, she will know post-operatively that she has drains, but she will not know if TissueGlu was utilized. The doctor will be aware of what treatment the patient is receiving, as he or she will administer the drug
Primary Purpose: Supportive Care
Official Title: Drain-Less Abdominally Based Breast Reconstruction Using a Novel Lysine-Derived Urethane Adhesive (TissueGlu, Cohera Medical)
Estimated Study Start Date : November 1, 2020
Estimated Primary Completion Date : February 1, 2021
Estimated Study Completion Date : September 1, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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 Name: 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 Name: 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




Primary Outcome Measures :
  1. Rate of seroma development [ Time Frame: Up to 30 days after surgery ]
    Number of seromas which develop during the first 30 days after surgery.


Secondary Outcome Measures :
  1. 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

  2. Pain Medicine Utilization [ Time Frame: Up to 4 weeks after surgery ]
    Use of pain medicine after surgery between groups, as indicated by chart review

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03159598


Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: Andrea Moreira, MD Cleveland Clinic, Case Comprehensive Cancer Center
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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03159598    
Other Study ID Numbers: CASE5117
First Posted: May 18, 2017    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020

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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
Keywords provided by Case Comprehensive Cancer Center:
A-BR
Abdominal-based breast reconstruction
Seroma
Additional relevant MeSH terms:
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Urethane
Antineoplastic Agents
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs