Skip to main content
OpenTrials
Completed

NCT Number: NCT01391988

Trial Comparing Electric and Harmonic Scalpel in Mastectomy

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Complication, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Hospital de Câncer de Barretos.

Barretos, São Paulo, 14.784.400, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Electric scalpel

Procedure

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

Harmonic scalpel

Procedure

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Barretos Cancer Hospital

Other

Registry information

Official study title

Prospective Trial Comparing the Use of Conventional Electric Scalpel and Harmonic Scalpel in Mastectomy

Acronym: Harmonic

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Jul 12, 2011
Registry last updated
Mar 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.