Trial Comparing Electric and Harmonic Scalpel in Mastectomy

Phase 3

Completed

• Conditions: Complication, Postoperative
• Interventions: Procedure: Harmonic scalpel; Procedure: Electric scalpel

• Registration Number: NCT01391988
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2008-01
• Primary Completion: 2008-11
• Study Completion: 2008-11
• Study First Submitted: 2011-06-24
• Study First Submitted QC: 2011-07-08
• Study First Posted: 2011-07-12
• Status Verified: 2014-03
• Last Update Submitted: 2014-03-06
• Last Update Posted: 2014-03-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 97

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Harmonic scalpel mastectomy	Harmonic scalpel	Radical Mastectomy with harmonic scalpel
Electric Scalpel Mastectomy	Electric scalpel	Radical mastectomy with electric scalpel

Primary Outcome Measures

Name	Time	Method
Differences in operative conditions and first week seroma drainage	1 week.	Time of the surgery and blood loss volume during surgery. Drain volume postoperative in the first week

Secondary Outcome Measures

Name	Time	Method
Differences in local complication	day 7 and day 14	Number of participants with adverse events as seroma, hematoma, skin necrosis and infection

Trial Locations

Locations (1)

Hospital de Câncer de Barretos.; 🇧🇷 Barretos, São Paulo, Brazil