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Completed

NCT Number: NCT07621575

Active Drainage vs. Passive Drainage in MRM

The aim of the study is to compare between active drainage and passive drainage in post-operative seroma formation after modified radical mastectomy in female patient with breast carcinoma as regard of:

Primary Outcomes:

1. Daily drain output (measured in mL/day). 2. Duration of the drain in place. 3. Amount of seroma aspiration after the drain removal. 4. Number of days till the last seroma aspiration.

Secondary Outcomes:

1. Flap necrosis. 2. Surgical site infection. 100 female divided into two equal groups:

* Group A: Active drainage group (50 patients). * Group B: Passive drainage group (50 patients). After MRM ,drain output was measured daily using a graduated jar by nurse during hospital stay which was a one to two days in an average and then by patient himself. All the data was recorded on a paper sheet. In passive drain, breast and axilla outcomes were combined together as one read to be equal to one active drain gar. Twice per week, I checked this reading by myself and reported any complications).

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Key information

Conditions

Modified Radical Mastectomy Brest Cancer Drain Effect Seroma Formation

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Egypt

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Female patient diagnosed with breast carcinoma planned for MRM

Exclusion criteria

  • • Previous breast surgery.
  • Active infection.
  • Recurrent or metastatic breast cancer (Stage IV).
  • Un-controlled diabetes mellitus (HbA1C >7).
  • Coagulopathy disease.
  • Use of anticoagulant or antiplatelet medications.
  • Bilateral breast cancer.
  • Loss to follow-up within one month of drain removal.
  • Pregnancy.
  • Male breast cancer patients.

Treatment and study plan

compare active and passive drain

Procedure

compare between active drainage and passive drainage in post-operative seroma formation after modified radical mastectomy in in amount ,duration, respiration ,respiration duration ,SSI and skin necrosis

Primary outcomes

  1. Daily drain output (mL/day)

    Time frame: 7 weeks for each case

    amount of drain output (mL/day)

Secondary outcomes

  1. Duration of the drain in place (in days)

    Time frame: 7 weeks for each case

    number of days of the drain in place

  2. Amount of seroma aspiration after the drain removal (mL)

    Time frame: 7 weeks for each case

    seroma aspirated in mL

  3. Number of days till the last seroma aspiration (in days)

    Time frame: 7 weeks for each case

    Number of days till the last seroma aspiration

  4. Flap necrosis

    Time frame: 7 weeks for each case

  5. Surgical site infection.

    Time frame: 7 weeks for each case

Sponsors and collaborators

Lead sponsor

MOHAMED GAMAL AHMED ARAKEEB

Other

Collaborators

  • Kafrelsheikh University

Registry information

Official study title

Comparison Between Active Drainage And Passive Drainage In Post-Operative Seroma Formation After Modified Radical Mastectomy In Female Patients With Breast Carcinoma: A Prospective Randomized Controlled Trial.

Acronym: MRM Drains

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 2, 2026
Registry last updated
Jun 2, 2026

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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