Breast Cancer
Conditions
Keywords
A-BR, Abdominal-based breast reconstruction, Seroma
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.
Interventions
DEVICETissue 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.
DEVICEDrain
Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery
OTHERQuestionnaires
Questionnaires given to patients pre-and post surgery to determine pain, impact of breast reconstruction on activity, and impact of breast reconstruction on caregivers
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)
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
Intervention model description
This study has three parallel groups. One experimental and two control groups
Eligibility
Sex/Gender
ALL
Age
22 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of seroma development | Up to 30 days after surgery | Number of seromas which develop during the first 30 days after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Pain Medicine Utilization | Up to 4 weeks after surgery | Use of pain medicine after surgery between groups, as indicated by chart review |
| 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 |
Outcome results
None listed