Single vs. Double Drain in Modified Radical Mastectomy

• Sponsor: Memon Medical Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT02411617
• Collaborator: (none)
• Enrollment: 176
• Arms: 2
• Duration (Months): 22

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Device: Drain	N/A

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 Design

• Study Type: Interventional
• Actual Enrollment: 176 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Single vs. Double Drain in Modified Radical Mastectomy: A Randomized Control Trial
• Study Start Date: Jan 1, 2013
• Actual Primary Completion Date: Nov 1, 2014
• Actual Study Completion Date: Nov 1, 2014

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. seroma formation [30 days post surgery]

   fluid collection beneath the flap sufficient to cause patient discomfort and pain

Secondary Outcome Measures

1. Duration of hospital stay,, [30 days after surgery]

2. wound infection [30 days after surgery]

   as described by center of disease control (CDC) criteria

3. postoperative pain [30 days after surgery]

   measured on visual analogue scale (1 to 10) in first 24 hours after surgery.

4. hematoma [30 days after surgery]

   blood collection under the flap

5. flap necrosis [30 days after surgery]

   flap discoloration due to compromised blood supply of flap

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Memon Medical Institute

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: salma khan, Consultant General Surgeon, Memon Medical Institute
• ClinicalTrials.gov Identifier: NCT02411617
• Other Study ID Numbers: ERC:02
• First Posted: Apr 8, 2015
• Last Update Posted: Apr 8, 2015
• Last Verified: Apr 1, 2015

Study Results

No Results Posted as of Apr 8, 2015