Drain-Less Abdominally Based Breast Reconstruction Using Lysine-Derived Urethane Adhesive
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 22 - 65 |
| Updated: | 2/10/2019 |
| Start Date: | May 2019 |
| End Date: | December 2019 |
| Contact: | Andrea Moreira, MD |
| Email: | moreira2@ccf.org |
| Phone: | 216-444-8542 |
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.
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.
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.
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.
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.
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