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Significant result achieved after enrollment of 31 of planned 50 subjects.
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| Name | Class |
|---|---|
| Ethicon Endo-Surgery | INDUSTRY |
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Purpose: The aims of this randomized clinical trial are to assess and compare 3 different outcomes in women undergoing breast reduction surgery using two different surgical devices: the Harmonic Scalpel and electrocautery.
The three metrics are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Harmonic Reduced Breast | Experimental | harmonic scalpel used to reduce breast on that side |
|
| Electrocautery Reduced Breast | Active Comparator | Electrocautery (current practice = control) used to reduce breast on that side |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Harmonic Scalpel | Device | harmonic scalpel used to reduce breast on this side |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Time for Operation | Time to complete the breast reduction per breast. | day of surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Volume of Drainage in Surgical Drains | An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour. | within one week of surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Carolyn L Kerrigan, MD | DHMC | Principal Investigator |
| Todd E Burdette, MD | DHMC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756 | United States |
Forty-three women were identified as potential study participants from May to December 2009. Three were excluded, because two were unable to consent and one was under 18 years old. Nine women declined to participate. Of the remaining 31 patients (72.1% of those identified), all completed the informed consent, the surgery, and the follow-up process.
Recruitment ran from January 2008 to January 2010. All patients were recruited in one surgical clinic at Dartmouth Hitchcock Medical Center.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Participants | All participants were randomized to have one breast reduced using the harmonic scalpel and the other breast using electrocautery. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | Participants randomized to have one breast reduced with harmonic scalpel and the other breast reduced with electrocautery. |
| 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 |
| 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 | Time for Operation | Time to complete the breast reduction per breast. | Women over the age of 18 who are not pregnant with symptomatic breast hypertrophy who underwent breast reduction surgery. | Posted | Median | Standard Deviation | minutes | day of surgery |
|
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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 | Harmonic Reduced Breast | harmonic scalpel used to reduce breast on that side |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Infected seroma | Skin and subcutaneous tissue disorders | Required operative evacuation, antibiotics and prolonged wound care. |
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We made a first analysis after 26 (intended enrollment 50) patients were enrolled and a result was strongly suggested. While the analysis was refined, 5 more patients enrolled. The study was then stopped after 31 patients enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carolyn L. Kerrigan MD | Dartmouth-Hitchcock | 603-650-5148 | carolyn.kerrigan@hitchcock.org |
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| ID | Term |
|---|---|
| D006965 | Hyperplasia |
| D000084462 | Hyperthermia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001832 | Body Temperature Changes |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D004564 | Electrocoagulation |
| ID | Term |
|---|---|
| D002425 | Cautery |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Electrocautery |
| Device |
Electrocautery used to reduce breast on this side |
|
| Pain Level in Surgical Sites |
An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable. |
| first week after surgery |
| Hematoma | A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery. | first day after surgery |
| Participants |
|
| Age Continuous | Median | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Volume of Drainage in Surgical Drains | An index was created to allow comparison between patients whose drain indwell times were different. This was created by taking total volume of drainage per breast drain and dividing it by the number of hours the drain was in place. The units are milliliters per hour. | All participants in the study. | Posted | Median | Standard Deviation | mL/hour | within one week of surgery |
|
|
|
| Secondary | Pain Level in Surgical Sites | An 11-point visual analog scale was used to obtain subjective pain levels from patients. 0 being no pain and 10 being worst pain imaginable. | all study participants | Posted | Median | Standard Deviation | units on a scale | first week after surgery |
|
|
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| Secondary | Hematoma | A collection of blood or uncontrolled bleeding that necessitates a return to the operating room in the first day after surgery. | entire study population | Posted | Number | participants | first day after surgery |
|
|
|
| 1 |
| 31 |
| 0 |
| 31 |
| EG001 | Electrocautery Reduced Breast | Electrocautery (current practice = control) used to reduce breast on that side | 0 | 31 | 0 | 31 |
|
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| D018882 | Heat Stress Disorders |
| D014947 | Wounds and Injuries |