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

NCT03159598 | Withdrawn DMC FDA Device

• 1 other identifier: CASE5117
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Breast Cancer

Keywords

A-BR; Abdominal-based breast reconstruction; Seroma

Outcome Measures

Primary Outcomes (1)

• Rate of seroma development

  Number of seromas which develop during the first 30 days after surgery.

  Up to 30 days after surgery

Secondary Outcomes (3)

• Difference in pain between patients with and without abdominal drains

  Up to 4 weeks after surgery

• Pain Medicine Utilization

  Up to 4 weeks after surgery

• Time to drain removal

  Up to 4 weeks after surgery

Study Arms (3)

Tissue Glu with drains

ACTIVE COMPARATOR

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; Device: Drain; Other: Questionnaires

Tissue Glu without drains

EXPERIMENTAL

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; Other: Questionnaires

Drains

ACTIVE COMPARATOR

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; Other: Questionnaires

Interventions

Tissue Glu DEVICE

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.

Also known as: TissuGlu, lysine-derived urethane adhesive

Tissue Glu with drains; Tissue Glu without drains

Drain DEVICE

Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery

Also known as: closed-suction drains

Drains; Tissue Glu with drains

Questionnaires OTHER

Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers

Drains; Tissue Glu with drains; Tissue Glu without drains

Eligibility Criteria

• Age: 22 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing Abdominally-Based Breast Reconstruction
• Both unilateral or bilateral reconstruction is allowed
• Both delayed or immediate reconstruction is allowed

You may not qualify if:

• Diabetes
• BMI\>30
• Active smokers.

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

MeSH Terms

Conditions

Breast Neoplasms; Seroma

Interventions

Drainage; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics; Surgical Procedures, Operative; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Andrea Moreira, MD

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study has three parallel groups. One experimental and two control groups

Study Record Dates

• First Submitted: May 17, 2017
• First Posted: May 18, 2017
• Study Start: November 1, 2020
• Primary Completion: February 1, 2021
• Study Completion: September 1, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11