Active Drainage vs. Passive Drainage in MRM

NCT07621575 | Completed DMC

• 1 other identifier: KFSIRB200-501
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• 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).

Conditions

Modified Radical Mastectomy; Drain Effect; Seroma Formation; Brest Cancer

Keywords

active Vs passive /MRM/suction drain

Outcome Measures

Primary Outcomes (1)

• Daily drain output (mL/day)

  amount of drain output (mL/day)

  7 weeks for each case

Secondary Outcomes (5)

• Duration of the drain in place (in days)

  7 weeks for each case

• Amount of seroma aspiration after the drain removal (mL)

  7 weeks for each case

• Number of days till the last seroma aspiration (in days)

  7 weeks for each case

• Flap necrosis

  7 weeks for each case

• Surgical site infection.

  7 weeks for each case

Study Arms (2)

Group A: Active drainage group

SHAM COMPARATOR

use of closed suction drain (18 F Hemovac drain)

Procedure: compare active and passive drain

Group B: Passive drainage group

ACTIVE COMPARATOR

use passive -gravity drainage (22F Penrose drain).

Procedure: compare active and passive drain

Interventions

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

Group A: Active drainage group; Group B: Passive drainage group

Eligibility Criteria

• Gender Eligibility Details: only female with breast cancer was enrolled
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patient diagnosed with breast carcinoma planned for MRM

You may not qualify if:

• 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.

Sponsors & Collaborators

• Kafrelsheikh University: collaborator
• MOHAMED GAMAL AHMED ARAKEEB: lead

Study Sites (1)

Kafrelsheikh University

Kafr ash Shaykh, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: surgical oncology resident at Tanta cancer center

Study Record Dates

• First Submitted: May 7, 2026
• First Posted: June 2, 2026
• Study Start: May 30, 2024
• Primary Completion: May 10, 2025
• Study Completion: November 15, 2025
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

EG (1)