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Trial Comparing Electric and Harmonic Scalpel in Mastectomy

NCT01391988 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 97

Last updated 2014-03-07

No results posted yet for this study

Summary

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

Conditions

  • Complication, Postoperative

Interventions

PROCEDURE

Electric scalpel

Radical mastectomy with electric scalpel. Electric scalpels were calibrated at 40 watts of cutting and coagulation power.

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

Sponsors & Collaborators

  • Barretos Cancer Hospital

    lead OTHER

Principal Investigators

  • Edmundo C Mauad, MD, PhD · Director from Barretos Cancer Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-31
Primary Completion
2008-11-30
Completion
2008-11-30

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01391988 on ClinicalTrials.gov