Active Drainage vs. Passive Drainage in MRM (MRM Drains)

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.

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).

Study Overview

• Status: Completed
• Conditions: Modified Radical Mastectomy; Brest Cancer; Drain Effect; Seroma Formation
• Intervention / Treatment: Procedure: compare active and passive drain

• Study Type: Interventional
• Enrollment (Actual): 157
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Kafr ash Shaykh, Egypt
    • Kafrelsheikh University

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Sham Comparator: Group A: Active drainage group; use of closed suction drain (18 F Hemovac drain)	Procedure: compare active and passive drain; 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
Active Comparator: Group B: Passive drainage group; use passive -gravity drainage (22F Penrose drain).	Procedure: compare active and passive drain; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily drain output (mL/day)	amount of drain output (mL/day)	7 weeks for each case

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of the drain in place (in days)	number of days of the drain in place	7 weeks for each case
Amount of seroma aspiration after the drain removal (mL)	seroma aspirated in mL	7 weeks for each case
Number of days till the last seroma aspiration (in days)	Number of days till the last seroma aspiration	7 weeks for each case
Flap necrosis		7 weeks for each case
Surgical site infection.		7 weeks for each case

Collaborators and Investigators

• Sponsor: MOHAMED GAMAL AHMED ARAKEEB
• Collaborators: Kafrelsheikh University

Study record dates

Study Major Dates

• Study Start (Actual): May 30, 2024
• Primary Completion (Actual): May 10, 2025
• Study Completion (Actual): November 15, 2025

Study Registration Dates

• First Submitted: May 7, 2026
• First Submitted That Met QC Criteria: May 29, 2026
• First Posted (Actual): June 2, 2026

Study Record Updates

• Last Update Posted (Actual): June 2, 2026
• Last Update Submitted That Met QC Criteria: May 29, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: active Vs passive /MRM/suction drain
• Other Study ID Numbers: KFSIRB200-501

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No