Breast Cancer
Conditions
Brief summary
Seroma is a common complication following modified radical mastectomy(MRM). Closed drainage is used routinely to reduce incidence of seroma. Usually two drains are used in patients who underwent MRM to reduce post operative seroma. It is often associated with significant patient discomfort and prolonged fluid drainage. The aim of this study is to evaluate effect of number of drains on seroma formation rate, postoperative pain and hospital stay during the immediate postoperative period after mastectomy for breast cancer.
Detailed description
Modified Radical mastectomy is commonly performed procedure for carcinoma breast. After surgery two drains are placed, one in axilla and one beneath the flap. The use of two drains is associated with significant post operative discomfort and pain. On the other hand two drains have not been proven to decrease post operative seroma formation.
Interventions
DEVICEDrain
Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain
Sponsors
Memon Medical Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* All female patients underwent MRM for biopsy proven carcinoma breast
Exclusion criteria
* Immediate reconstruction * Patient refusal to participate in study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| seroma formation | 30 days post surgery | fluid collection beneath the flap sufficient to cause patient discomfort and pain |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Duration of hospital stay,, | 30 days after surgery | — |
| wound infection | 30 days after surgery | as described by center of disease control (CDC) criteria |
| postoperative pain | 30 days after surgery | measured on visual analogue scale (1 to 10) in first 24 hours after surgery. |
| hematoma | 30 days after surgery | blood collection under the flap |
| flap necrosis | 30 days after surgery | flap discoloration due to compromised blood supply of flap |
Outcome results
None listed