Trial Comparing Electric and Harmonic Scalpel in Mastectomy
NCT ID: NCT01391988
Last Updated: 2014-03-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
97 participants
INTERVENTIONAL
2008-01-31
2008-11-30
Brief Summary
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Detailed Description
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Electric scalpels were calibrated at 40 watts of cutting and coagulation power and harmonic scalpel with a GEN04 generator calibrated at power levels 3 and 5, using the HP054 handpiece and HF105 curved blade.
Local postoperative complications analysed were seroma, hematoma, skin necrosis and infection.
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Electric Scalpel Mastectomy
Radical mastectomy with electric scalpel
Electric scalpel
Radical mastectomy with electric scalpel. Electric scalpels were calibrated at 40 watts of cutting and coagulation power.
Harmonic scalpel mastectomy
Radical Mastectomy with harmonic scalpel
Harmonic scalpel
Radical mastectomy with harmonic scalpel. Harmonic GEN04 generator calibrated at power leve 3 and 5, using the HP054 handpiece and HF 105 curved blade
Interventions
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Electric scalpel
Radical mastectomy with electric scalpel. Electric scalpels were calibrated at 40 watts of cutting and coagulation power.
Harmonic scalpel
Radical mastectomy with harmonic scalpel. Harmonic GEN04 generator calibrated at power leve 3 and 5, using the HP054 handpiece and HF 105 curved blade
Eligibility Criteria
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Inclusion Criteria
* Modified radical mastectomy was the surgery to be realized
* Blood dyscrasia, collagen diseases, known uncontrolled chronic diseases, infections (mammary or axillary), ulcerated tumors and pregnancy
18 Years
FEMALE
No
Sponsors
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Barretos Cancer Hospital
OTHER
Responsible Party
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Principal Investigators
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Edmundo C Mauad, MD, PhD
Role: STUDY_DIRECTOR
Director from Barretos Cancer Hospital
Locations
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Hospital de Câncer de Barretos.
Barretos, São Paulo, Brazil
Countries
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References
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Lumachi F, Brandes AA, Burelli P, Basso SM, Iacobone M, Ermani M. Seroma prevention following axillary dissection in patients with breast cancer by using ultrasound scissors: a prospective clinical study. Eur J Surg Oncol. 2004 Jun;30(5):526-30. doi: 10.1016/j.ejso.2004.03.003.
Lumachi F, Burelli P, Basso SM, Iacobone M, Ermani M. Usefulness of ultrasound scissors in reducing serous drainage after axillary dissection for breast cancer: a prospective randomized clinical study. Am Surg. 2004 Jan;70(1):80-4.
Kozomara D, Galic G, Brekalo Z, Sutalo N, Kvesic A, Soljic M. A randomised two-way comparison of mastectomy performed using harmonic scalpel or monopolar diathermy. Coll Antropol. 2010 Mar;34 Suppl 1:105-12.
Kurtz SB, Frost DB. A comparison of two surgical techniques for performing mastectomy. Eur J Surg Oncol. 1995 Apr;21(2):143-5. doi: 10.1016/s0748-7983(95)90171-x.
Deo SV, Shukla NK, Asthana S, Niranjan B, Srinivas G. A comparative study of modified radical mastectomy using harmonic scalpel and electrocautery. Singapore Med J. 2002 May;43(5):226-8.
Galatius H, Okholm M, Hoffmann J. Mastectomy using ultrasonic dissection: effect on seroma formation. Breast. 2003 Oct;12(5):338-41. doi: 10.1016/s0960-9776(03)00110-3.
Adwani A, Ebbs SR. Ultracision reduces acute blood loss but not seroma formation after mastectomy and axillary dissection: a pilot study. Int J Clin Pract. 2006 May;60(5):562-4. doi: 10.1111/j.1742-1241.2006.00689.x.
Miller E, Paull DE, Morrissey K, Cortese A, Nowak E. Scalpel versus electrocautery in modified radical mastectomy. Am Surg. 1988 May;54(5):284-6.
Ribeiro GH, Kerr LM, Haikel RL, Peres SV, Matthes AG, Depieri Michelli RA, Bailao A Jr, Fregnani JH, Vieira RA. Modified radical mastectomy: a pilot clinical trial comparing the use of conventional electric scalpel and harmonic scalpel. Int J Surg. 2013;11(6):496-500. doi: 10.1016/j.ijsu.2013.03.013. Epub 2013 Apr 8.
Other Identifiers
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133/2008 HCB
Identifier Type: -
Identifier Source: org_study_id
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