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PI left institution, never submitted to IRB
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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.
Objectives:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
|
| 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 |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of seroma development | Number of seromas which develop during the first 30 days after surgery. | Up to 30 days after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in pain between patients with and without abdominal drains | Patients will be given a questionnaire pre-operatively and the same questionnaire post-operatively. The change in these questionnaires will be compared between groups | Up to 4 weeks after surgery |
| Pain Medicine Utilization |
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Inclusion Criteria:
Patients undergoing Abdominally-Based Breast Reconstruction
Both delayed or immediate reconstruction is allowed
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrea Moreira, MD | Cleveland Clinic, Case Comprehensive Cancer Center | Principal Investigator |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D049291 | Seroma |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D004322 | Drainage |
| D011795 | Surveys and Questionnaires |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D013514 | Surgical Procedures, Operative |
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
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This study has three parallel groups. One experimental and two control groups
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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
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| Drain | Device | Drains will be placed during surgery to allow for the drainage of seroma which may develop after surgery |
|
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| 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 |
|
Use of pain medicine after surgery between groups, as indicated by chart review |
| Up to 4 weeks after surgery |
| Time to drain removal | Time from surgery to the removal of the drain for any reason, in patients who were given a drain | Up to 4 weeks after surgery |
| D017437 |
| Skin and Connective Tissue Diseases |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008919 |
| Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |