Trial Comparing Electric and Harmonic Scalpel in Mastectomy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital
ClinicalTrials.gov Identifier:
NCT01391988
First received: June 24, 2011
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

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


Condition Intervention Phase
Complication, Postoperative
Procedure: Electric scalpel
Procedure: Harmonic scalpel
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Prospective Trial Comparing the Use of Conventional Electric Scalpel and Harmonic Scalpel in Mastectomy

Resource links provided by NLM:


Further study details as provided by Barretos Cancer Hospital:

Primary Outcome Measures:
  • Differences in operative conditions and first week seroma drainage [ Time Frame: 1 week. ] [ Designated as safety issue: Yes ]
    Time of the surgery and blood loss volume during surgery. Drain volume postoperative in the first week


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


Enrollment: 97
Study Start Date: January 2008
Study Completion Date: November 2008
Primary Completion Date: November 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:
Additional 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
Study First Received: June 24, 2011
Last Updated: March 6, 2014
Health Authority: Brazil: National Committee of Ethics in Research

Additional relevant MeSH terms:
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on September 15, 2014