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

Not Applicable

Withdrawn

• Conditions: Breast Cancer

• Registration Number: NCT03159598
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2017-05-17
• Study First Submitted QC: 2017-05-17
• Study First Posted: 2017-05-18
• Status Verified: 2020-11
• Study Start: 2020-11-01
• Last Update Submitted: 2020-11-20
• Last Update Posted: 2020-11-24
• Primary Completion: 2021-02-01
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Pain Medicine Utilization	Up to 4 weeks after surgery	Use of pain medicine after surgery between groups, as indicated by chart review
Difference in pain between patients with and without abdominal drains	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
Time to drain removal	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