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Trial Comparing Electric and Harmonic Scalpel in Mastectomy (Harmonic)

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ClinicalTrials.gov Identifier: NCT01391988
Recruitment Status : Completed
First Posted : July 12, 2011
Last Update Posted : March 7, 2014
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital

Brief Summary:
Prospective trial comparing post-operative complications and seroma formation after mastectomy in patients with breast cancer, using conventional electric scalpel and harmonic scalpel.

Condition or disease Intervention/treatment Phase
Complication, Postoperative Procedure: Electric scalpel Procedure: Harmonic scalpel Phase 3

Detailed Description:

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mastectomy

Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Differences in local complication [ Time Frame: day 7 and day 14 ]
    Number of participants with adverse events as seroma, hematoma, skin necrosis and infection



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Women with breast cancer candidate to a radical mastectomy during the year of 2008.

Prospective trial with women stratified consecutive.

Inclusion Criteria:

  • Breast carcinoma (ductal or lobular)
  • Modified radical mastectomy was the surgery to be realized

Exclusion Criteria:

  • Not inclusion criteria
  • Blood dyscrasia, collagen diseases, known uncontrolled chronic diseases, infections (mammary or axillary), ulcerated tumors and pregnancy

Information from the National Library of Medicine

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


Locations
Brazil
Hospital de Câncer de Barretos.
Barretos, São Paulo, Brazil, 14.784.400
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
Study Director: Edmundo C Mauad, MD, PhD Director from Barretos Cancer Hospital

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT01391988     History of Changes
Other Study ID Numbers: 133/2008 HCB
First Posted: July 12, 2011    Key Record Dates
Last Update Posted: March 7, 2014
Last Verified: March 2014

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes