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OpenTrials
Completed

NCT Number: NCT02411617

Single vs. Double Drain in Modified Radical Mastectomy

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • All female patients underwent MRM for biopsy proven carcinoma breast

Exclusion criteria

  • Immediate reconstruction
  • Patient refusal to participate in study

Treatment and study plan

Drain

Device

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

Primary outcomes

  1. seroma formation

    Time frame: 30 days post surgery

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

Secondary outcomes

  1. Duration of hospital stay,,

    Time frame: 30 days after surgery

  2. wound infection

    Time frame: 30 days after surgery

    as described by center of disease control (CDC) criteria

  3. postoperative pain

    Time frame: 30 days after surgery

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

  4. hematoma

    Time frame: 30 days after surgery

    blood collection under the flap

  5. flap necrosis

    Time frame: 30 days after surgery

    flap discoloration due to compromised blood supply of flap

Sponsors and collaborators

Lead sponsor

Memon Medical Institute

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 8, 2015
Registry last updated
Apr 8, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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