Single vs. Double Drain in Modified Radical Mastectomy

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Drain

• Registration Number: NCT02411617
• Lead Sponsor: Memon Medical Institute

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.

Study Timeline

• Study Start: 2013-01
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Study First Submitted: 2015-02-27
• Status Verified: 2015-04
• Study First Submitted QC: 2015-04-02
• Last Update Submitted: 2015-04-02
• Study First Posted: 2015-04-08
• Last Update Posted: 2015-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 176

Inclusion Criteria

• All female patients underwent MRM for biopsy proven carcinoma breast

Exclusion Criteria

• Immediate reconstruction
• Patient refusal to participate in study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Double drain in modified radical mastectomy	Drain	Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain
Single drain in modified radical mastectomy	Drain	Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain

Primary Outcome Measures

Name	Time	Method
seroma formation	30 days post surgery	fluid collection beneath the flap sufficient to cause patient discomfort and pain

Secondary Outcome Measures

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