Complication, Postoperative
Conditions
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.
Interventions
PROCEDUREElectric scalpel
Radical mastectomy with electric scalpel. Electric scalpels were calibrated at 40 watts of cutting and coagulation power.
PROCEDUREHarmonic 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
Barretos Cancer Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Differences in local complication | day 7 and day 14 | Number of participants with adverse events as seroma, hematoma, skin necrosis and infection |
Countries
Brazil
Outcome results
None listed