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Trial Comparing Electric and Harmonic Scalpel in Mastectomy (Harmonic)

Primary Purpose

Complication, Postoperative

Status
Completed
Phase
Phase 3
Locations
Brazil
Study Type
Interventional
Intervention
Electric scalpel
Harmonic scalpel
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Complication, Postoperative

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital de Câncer de Barretos.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Electric Scalpel Mastectomy

Harmonic scalpel mastectomy

Arm Description

Radical mastectomy with electric scalpel

Radical Mastectomy with harmonic scalpel

Outcomes

Primary Outcome Measures

Differences in operative conditions and first week seroma drainage
Time of the surgery and blood loss volume during surgery. Drain volume postoperative in the first week

Secondary Outcome Measures

Differences in local complication
Number of participants with adverse events as seroma, hematoma, skin necrosis and infection

Full Information

First Posted
June 24, 2011
Last Updated
March 6, 2014
Sponsor
Barretos Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01391988
Brief Title
Trial Comparing Electric and Harmonic Scalpel in Mastectomy
Acronym
Harmonic
Official Title
Prospective Trial Comparing the Use of Conventional Electric Scalpel and Harmonic Scalpel in Mastectomy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2008 (Actual)
Study Completion Date
November 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barretos Cancer Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Complication, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
97 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Electric Scalpel Mastectomy
Arm Type
Active Comparator
Arm Description
Radical mastectomy with electric scalpel
Arm Title
Harmonic scalpel mastectomy
Arm Type
Experimental
Arm Description
Radical Mastectomy with harmonic scalpel
Intervention Type
Procedure
Intervention Name(s)
Electric scalpel
Intervention Description
Radical mastectomy with electric scalpel. Electric scalpels were calibrated at 40 watts of cutting and coagulation power.
Intervention Type
Procedure
Intervention Name(s)
Harmonic scalpel
Intervention Description
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 Measure Information:
Title
Differences in operative conditions and first week seroma drainage
Description
Time of the surgery and blood loss volume during surgery. Drain volume postoperative in the first week
Time Frame
1 week.
Secondary Outcome Measure Information:
Title
Differences in local complication
Description
Number of participants with adverse events as seroma, hematoma, skin necrosis and infection
Time Frame
day 7 and day 14

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edmundo C Mauad, MD, PhD
Organizational Affiliation
Director from Barretos Cancer Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hospital de Câncer de Barretos.
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14.784.400
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
15135481
Citation
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.
Results Reference
background
PubMed Identifier
14964555
Citation
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.
Results Reference
background
PubMed Identifier
20402305
Citation
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.
Results Reference
background
PubMed Identifier
7720886
Citation
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.
Results Reference
background
PubMed Identifier
12188072
Citation
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.
Results Reference
background
PubMed Identifier
14659149
Citation
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.
Results Reference
background
PubMed Identifier
16700855
Citation
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.
Results Reference
background
PubMed Identifier
3364865
Citation
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.
Results Reference
background
PubMed Identifier
23579255
Citation
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.
Results Reference
derived

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Trial Comparing Electric and Harmonic Scalpel in Mastectomy

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