Single vs. Double Drain in Modified Radical Mastectomy

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

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Drain

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 Type: Interventional
• Enrollment (Actual): 176
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• All female patients underwent MRM for biopsy proven carcinoma breast

Exclusion Criteria:

• Immediate reconstruction
• Patient refusal to participate in study

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Memon Medical Institute

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: February 27, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Estimate): April 8, 2015
• Last Update Submitted That Met QC Criteria: April 2, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: ERC:02