Trial Comparing Electric and Harmonic Scalpel in Mastectomy (Harmonic)
|Complication, Postoperative||Procedure: Electric scalpel Procedure: Harmonic scalpel||Phase 3|
|Study Design:||Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Participant)
Primary Purpose: Treatment
|Official Title:||Prospective Trial Comparing the Use of Conventional Electric Scalpel and Harmonic Scalpel in Mastectomy|
- 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
|Study Start Date:||January 2008|
|Study Completion Date:||November 2008|
|Primary Completion Date:||November 2008 (Final data collection date for primary outcome measure)|
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
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|