Modified Radical MastectomyMRM DrainsNCT07621575
Active Drainage vs. Passive Drainage in MRM
A study testing compare active and passive drain in people with Modified Radical Mastectomy and Drain Effect, run by MOHAMED GAMAL AHMED ARAKEEB at 1 site in Egypt.
Trial 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: 1. Daily drain output (measured in mL/day). 2. Duration of the drain in place. 3. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Modified Radical Mastectomy, Drain Effect, Seroma Formation
- What is being tested?
- compare active and passive drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 157 participants
- Where
- 1 siteEgypt
- Study dates
- 30 May 2024to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Female patient diagnosed with breast carcinoma planned for MRM
Who cannot join
- • 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.
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- Bilateral breast cancer.
- Loss to follow-up within one month of drain removal.
- Pregnancy.
- Male breast cancer patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
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:
Read more
- Daily drain output (measured in mL/day).
- Duration of the drain in place.
- Amount of seroma aspiration after the drain removal.
- Number of days till the last seroma aspiration.
Secondary Outcomes:
- Flap necrosis.
- 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).
- Being tested
- compare active and passive drain
- Keywords
- active Vs passive /MRM/suction drain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compare active and passive drainProcedure or surgery
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
| Study group | Role | What they receive |
|---|---|---|
| Group A: Active drainage group | Sham comparator | use of closed suction drain (18 F Hemovac drain) Receives: Procedure: compare active and passive drain |
| Group B: Passive drainage group | Active comparator | use passive -gravity drainage (22F Penrose drain). Receives: Procedure: compare active and passive drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Daily drain output (mL/day)
amount of drain output (mL/day)
Measured: 7 weeks for each case
Secondary outcomes (5)
Duration of the drain in place (in days)
number of days of the drain in place
Measured: 7 weeks for each case
Amount of seroma aspiration after the drain removal (mL)
seroma aspirated in mL
Measured: 7 weeks for each case
Number of days till the last seroma aspiration (in days)
Number of days till the last seroma aspiration
Measured: 7 weeks for each case
Flap necrosis
Measured: 7 weeks for each case
Surgical site infection.
Measured: 7 weeks for each case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2026
- Study start30 May 2024
- Primary completion10 May 2025
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Modified Radical MastectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- MOHAMED GAMAL AHMED ARAKEEB
- Sponsor type
- University, hospital or other
- Collaborators
- Kafrelsheikh University
- Responsible party
- Sponsor-investigator, MOHAMED GAMAL AHMED ARAKEEB, Kafrelsheikh University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07621575
- Sponsor's protocol ID
- KFSIRB200-501
- Acronym
- MRM Drains
- Status last verified
- May 2026
- First submitted
- 7 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07621575
- Acronym / sponsor ID
- MRM Drains / KFSIRB200-501
- Keywords
- active Vs passive /MRM/suction drain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- MOHAMED GAMAL AHMED ARAKEEBUniversity, hospital or other
- Collaborators
- Kafrelsheikh University
- Study start
- 30 May 2024 (actual)
- Primary completion
- 10 May 2025 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 2 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Daily drain output (measured in mL/day).
- Duration of the drain in place.
- Amount of seroma aspiration after the drain removal.
- Number of days till the last seroma aspiration.
Secondary Outcomes:
- Flap necrosis.
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: Active drainage group | Sham comparator | Procedure: compare active and passive drainuse of closed suction drain (18 F Hemovac drain) |
| Group B: Passive drainage group | Active comparator | Procedure: compare active and passive drainuse passive -gravity drainage (22F Penrose drain). |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Female patient diagnosed with breast carcinoma planned for MRM
Key exclusion criteria (10 listed)
- • Previous breast surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| compare active and passive draincompare 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 | Procedure or surgery | Group A: Active drainage group, Group B: Passive drainage group |
Primary outcome
Daily drain output (mL/day)
Time frame: 7 weeks for each case
amount of drain output (mL/day)
5 secondary outcomes
Duration of the drain in place (in days)
Time frame: 7 weeks for each case
Amount of seroma aspiration after the drain removal (mL)
Time frame: 7 weeks for each case
Number of days till the last seroma aspiration (in days)
Time frame: 7 weeks for each case
Flap necrosis
Time frame: 7 weeks for each case
Surgical site infection.
Time frame: 7 weeks for each case
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing compare active and passive drain in people with Modified Radical Mastectomy and Drain Effect, run by MOHAMED GAMAL AHMED ARAKEEB at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Daily drain output (mL/day) (time frame: 7 weeks for each case). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026; AzTrials last refreshed its copy on 27 Oct 2026.