Single vs. Double Drain in Modified Radical Mastectomy

Study Overview
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Brief Summary
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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
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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.

Official Title
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Single vs. Double Drain in Modified Radical Mastectomy: A Randomized Control Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Drain


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All female patients underwent MRM for biopsy proven carcinoma breast Exclusion Criteria: Immediate reconstruction Patient refusal to participate in study
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Single drain in modified radical mastectomy<br>Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain | Device: Drain<br>* Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain<br>|
| Active Comparator: Double drain in modified radical mastectomy<br>Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain | Device: Drain<br>* Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seroma formation | fluid collection beneath the flap sufficient to cause patient discomfort and pain | 30 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of hospital stay,, |  | 30 days after surgery | 
| wound infection | as described by center of disease control (CDC) criteria | 30 days after surgery | 
| postoperative pain | measured on visual analogue scale (1 to 10) in first 24 hours after surgery. | 30 days after surgery | 
| hematoma | blood collection under the flap | 30 days after surgery | 
| flap necrosis | flap discoloration due to compromised blood supply of flap | 30 days after surgery |