Trial Comparing Electric and Harmonic Scalpel in Mastectomy (Harmonic)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01391988|
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : March 7, 2014
|Condition or disease||Intervention/treatment||Phase|
|Complication, Postoperative||Procedure: Electric scalpel Procedure: Harmonic scalpel||Phase 3|
The population of this study was formed by women aged older than 18 years old, with breast carcinoma (ductal ou lobular) at any stage, form whom modified radical mastectomy is proposed. Patients were excluded if the present blood dyscrasia, collagen diseases, known uncontrolled chronic disease, infections (mammary or axillary, ulcerated tumors and pregnancy. The women were submitted to modified radical mastectomy consecutive allocated in electric scalpel group and the other group with harmonic scalpel.
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||97 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Prospective Trial Comparing the Use of Conventional Electric Scalpel and Harmonic Scalpel in Mastectomy|
|Study Start Date :||January 2008|
|Actual Primary Completion Date :||November 2008|
|Actual Study Completion Date :||November 2008|
Active Comparator: Electric Scalpel Mastectomy
Radical mastectomy with electric scalpel
Procedure: Electric scalpel
Radical mastectomy with electric scalpel. Electric scalpels were calibrated at 40 watts of cutting and coagulation power.
Experimental: Harmonic scalpel mastectomy
Radical Mastectomy with harmonic scalpel
Procedure: 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
- Differences in operative conditions and first week seroma drainage [ Time Frame: 1 week. ]Time of the surgery and blood loss volume during surgery. Drain volume postoperative in the first week
- Differences in local complication [ Time Frame: day 7 and day 14 ]Number of participants with adverse events as seroma, hematoma, skin necrosis and infection
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01391988
|Hospital de Câncer de Barretos.|
|Barretos, São Paulo, Brazil, 14.784.400|
|Study Director:||Edmundo C Mauad, MD, PhD||Director from Barretos Cancer Hospital|