Brest Cancer, Drain Effect, Modified Radical Mastectomy, Seroma Formation
Conditions
Keywords
active Vs passive /MRM/suction drain
Brief summary
The aim of the study is to compare between active drainage and passive drainage in post-operative seroma formation after modified radical mastectomy in female patient with breast carcinoma as regard of: Primary Outcomes: 1. Daily drain output (measured in mL/day). 2. Duration of the drain in place. 3. Amount of seroma aspiration after the drain removal. 4. Number of days till the last seroma aspiration. Secondary Outcomes: 1. Flap necrosis. 2. Surgical site infection. 100 female divided into two equal groups: * Group A: Active drainage group (50 patients). * Group B: Passive drainage group (50 patients). After MRM ,drain output was measured daily using a graduated jar by nurse during hospital stay which was a one to two days in an average and then by patient himself. All the data was recorded on a paper sheet. In passive drain, breast and axilla outcomes were combined together as one read to be equal to one active drain gar. Twice per week, I checked this reading by myself and reported any complications).
Interventions
PROCEDUREcompare active and passive drain
compare between active drainage and passive drainage in post-operative seroma formation after modified radical mastectomy in in amount ,duration, respiration ,respiration duration ,SSI and skin necrosis
Sponsors
MOHAMED GAMAL AHMED ARAKEEB
Kafrelsheikh University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Female patient diagnosed with breast carcinoma planned for MRM
Exclusion criteria
* • Previous breast surgery. * Active infection. * Recurrent or metastatic breast cancer (Stage IV). * Un-controlled diabetes mellitus (HbA1C \>7). * Coagulopathy disease. * Use of anticoagulant or antiplatelet medications. * Bilateral breast cancer. * Loss to follow-up within one month of drain removal. * Pregnancy. * Male breast cancer patients.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Daily drain output (mL/day) | 7 weeks for each case | amount of drain output (mL/day) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of the drain in place (in days) | 7 weeks for each case | number of days of the drain in place |
| Amount of seroma aspiration after the drain removal (mL) | 7 weeks for each case | seroma aspirated in mL |
| Number of days till the last seroma aspiration (in days) | 7 weeks for each case | Number of days till the last seroma aspiration |
| Flap necrosis | 7 weeks for each case | — |
| Surgical site infection. | 7 weeks for each case | — |
Countries
Egypt
Outcome results
None listed