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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2012-00809 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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Low patient enrollment and no clinical findings.
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| Name | Class |
|---|---|
| Oregon Health and Science University | OTHER |
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The purpose of this study is to investigate the efficacy of an alternative surgical technique and the use of fibrin sealant in preventing post-operative seroma formation. A seroma is a build-up of clear bodily fluids in a place on the body where tissue has been removed by surgery. Seromas can happen after breast surgeries. Seromas can appear about 7 to 10 days after surgery, after the drainage tubes have been removed. The breast area involved in the surgery may have a spot that's swollen and feels like there is liquid under the skin
PRIMARY OBJECTIVES:
I. To evaluate differing surgical techniques (sharp dissection v. electrosurgical, use of fibrin glue) in latissimus dorsi donor flap harvest and their effect, if any on the prevention of post-operative seromas.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients undergo sharp dissection technique with fibrin sealant closure.
ARM II: Patients undergo standard electrocoagulation dissection technique.
After completion of study treatment, patients are followed up for 90-180 days.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (fibrin sealant) | Experimental | Patients undergo sharp dissection technique with fibrin sealant closure. |
|
| Arm II (standard electrocoagulation) | Active Comparator | Patients undergo standard electrocoagulation dissection technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fibrin sealant (Beriplast P, TISSEEL VH) | Drug | Applied topically |
|
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients in Each Arm Who Develop Post-operative Seromas | Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups. | Up to day 180 post-operation |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications | Computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the wound complication rate are significantly different for the two treatment groups, and the odds ratio with 95% confidence interval will be computed. | Up to day 180 post-operation |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Juliana Hansen | OHSU Knight Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OHSU Knight Cancer Institute | Portland | Oregon | 97239 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Fibrin Sealant) | Patients undergo sharp dissection technique with fibrin sealant closure. breast reconstruction : Undergo sharp dissection technique fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically |
| FG001 | Arm II (Standard Electrocoagulation) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| breast reconstruction | Procedure | Undergo sharp dissection technique |
|
|
| breast reconstruction | Procedure | Undergo electrocoagulation dissection technique |
|
|
| Quantity of Post-operative Drainage | Defined as total volume of drainage recorded (in ml) by nurses while the patient is in the hospital and by patient himself/herself when discharged home, until the removal of the drain by a doctor once it reaches less than 50 ml per day. Wilcoxon rank sum test will be used to compare the drainage volume of the two groups. | Up to day 10 post-operation |
| Serious and Nonserious Adverse Events and Complications | Up to day 180 post-operation |
Patients undergo standard electrocoagulation dissection technique. breast reconstruction : Undergo electrocoagulation dissection technique |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Fibrin Sealant) | Patients undergo sharp dissection technique with fibrin sealant closure. breast reconstruction : Undergo sharp dissection technique fibrin sealant (Beriplast P, TISSEEL VH) : Applied topically |
| BG001 | Arm II (Standard Electrocoagulation) | Patients undergo standard electrocoagulation dissection technique. breast reconstruction : Undergo electrocoagulation dissection technique |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Proportion of Patients in Each Arm Who Develop Post-operative Seromas | Computed with 95% confidence interval using exact method. The difference of seroma rate in the two groups will be computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the seroma rate are significantly different for the two treatment groups. | Data was not collected due to early termination and very low accrual | Posted | Up to day 180 post-operation |
|
| ||||||||||||||||||||||
| Secondary | Proportion of Patients Who Experienced Wound Infections, Wound Separation, or Any Other Surgical Complications | Computed with 95% confidence interval using exact method. Two-sided Fisher's exact test will be used to evaluate whether the wound complication rate are significantly different for the two treatment groups, and the odds ratio with 95% confidence interval will be computed. | Data was not collected due to early termination and very low accrual | Posted | Up to day 180 post-operation |
|
| ||||||||||||||||||||||
| Secondary | Quantity of Post-operative Drainage | Defined as total volume of drainage recorded (in ml) by nurses while the patient is in the hospital and by patient himself/herself when discharged home, until the removal of the drain by a doctor once it reaches less than 50 ml per day. Wilcoxon rank sum test will be used to compare the drainage volume of the two groups. | Data was not collected due to early termination and very low accrual | Posted | Up to day 10 post-operation |
|
| ||||||||||||||||||||||
| Secondary | Serious and Nonserious Adverse Events and Complications | Data was not collected due to early termination and very low accrual | Posted | Up to day 180 post-operation |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Fibrin Sealant) | Patients undergo sharp dissection technique with fibrin sealant closure. | 0 | 1 | 0 | 1 | ||
| EG001 | Arm II (Standard Electrocoagulation) | Patients undergo standard electrocoagulation dissection technique. | 0 | 1 | 0 | 1 |
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Data was not collected due to early termination and very low accrual.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Juliana Hansen | Oregon Health and Science University | 503-494-4834 | hansenju@ohsu.edu |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D011183 | Postoperative Complications |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D015718 | Fibrin Tissue Adhesive |
| D016462 | Mammaplasty |
| ID | Term |
|---|---|
| D005337 | Fibrin |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D019651 | Plastic Surgery Procedures |
| D013514 | Surgical Procedures, Operative |
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| >=65 years |
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| Male |
|