Clinical trial NCT03159598: Drain-Less Abdominally Based Breast Reconstruction Using Lysine-Derived Urethane Adhesive
Official title: Drain-Less Abdominally Based Breast Reconstruction Using a Novel Lysine-Derived Urethane Adhesive (TissueGlu, Cohera Medical)
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Breast Cancer
Keywords: A-BR
Abdominal-based breast reconstruction
Seroma
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-05-18
Enrollment: 0
Sex: ALL
Minimum age (years): 22
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study has three parallel groups. One experimental and two control groups
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Rate of seroma development
timeFrame: Up to 30 days after surgery
Secondary outcomes:
measure: Difference in pain between patients with and without abdominal drains
timeFrame: Up to 4 weeks after surgery
measure: Pain Medicine Utilization
timeFrame: Up to 4 weeks after surgery
measure: Time to drain removal
timeFrame: Up to 4 weeks after surgery
Other outcomes:
Locations:
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Andrea Moreira, MD
role: PRINCIPAL_INVESTIGATOR
References: