Trial Comparing Electric and Harmonic Scalpel in Mastectomy

Complication, Postoperative Clinical Trial

— Harmonic  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01391988
• Other study ID #: 133/2008 HCB
• Status: Completed
• Phase: Phase 3
• First received: June 24, 2011
• Last updated: March 6, 2014
• Start date: January 2008
• Est. completion date: November 2008

Study information

• Verified date: March 2014
• Source: Barretos Cancer Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 97
• Est. completion date: November 2008
• Est. primary completion date: November 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Complication, Postoperative
• Postoperative Complications

Intervention

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

Locations

Country	Name	City	State
Brazil	Hospital de Câncer de Barretos.	Barretos	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
Barretos Cancer Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (8)

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. — View 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. — View Citation

Galatius H, Okholm M, Hoffmann J. Mastectomy using ultrasonic dissection: effect on seroma formation. Breast. 2003 Oct;12(5):338-41. — View 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. — View Citation

Kurtz SB, Frost DB. A comparison of two surgical techniques for performing mastectomy. Eur J Surg Oncol. 1995 Apr;21(2):143-5. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 week.	Yes
Secondary	Differences in local complication	Number of participants with adverse events as seroma, hematoma, skin necrosis and infection	day 7 and day 14	Yes