Single vs. Double Drain in Modified Radical Mastectomy

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02411617
• Other study ID #: ERC:02
• Status: Completed
• Phase: N/A
• First received: February 27, 2015
• Last updated: April 2, 2015
• Start date: January 2013
• Est. completion date: November 2014

Study information

• Verified date: April 2015
• Source: Memon Medical Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Pakistan: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 176
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• All female patients underwent MRM for biopsy proven carcinoma breast

Exclusion Criteria:

• Immediate reconstruction

• Patient refusal to participate in study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Drain
Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Memon Medical Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	seroma formation	fluid collection beneath the flap sufficient to cause patient discomfort and pain	30 days post surgery	No
Secondary	Duration of hospital stay,,		30 days after surgery	No
Secondary	wound infection	as described by center of disease control (CDC) criteria	30 days after surgery	No
Secondary	postoperative pain	measured on visual analogue scale (1 to 10) in first 24 hours after surgery.	30 days after surgery	No
Secondary	hematoma	blood collection under the flap	30 days after surgery	No
Secondary	flap necrosis	flap discoloration due to compromised blood supply of flap	30 days after surgery	No