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Trial Comparing Electric and Harmonic Scalpel in Mastectomy

B

Barretos Cancer Hospital

Status and phase

Completed
Phase 3

Conditions

Complication, Postoperative

Treatments

Procedure: Harmonic scalpel
Procedure: Electric scalpel

Study type

Interventional

Funder types

Other

Identifiers

NCT01391988
133/2008 HCB

Details and patient eligibility

About

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

Full 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.

Enrollment

97 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

97 participants in 2 patient groups

Electric Scalpel Mastectomy
Active Comparator group
Description:
Radical mastectomy with electric scalpel
Treatment:
Procedure: Electric scalpel
Harmonic scalpel mastectomy
Experimental group
Description:
Radical Mastectomy with harmonic scalpel
Treatment:
Procedure: Harmonic scalpel

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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