Breast CancerNCT02411617
Single vs. Double Drain in Modified Radical Mastectomy
A study testing Drain in people with Breast Cancer, run by Memon Medical Institute.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Drain
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- No sites listed yet
- Study dates
- Jan 2013to Nov 2014
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All female patients underwent MRM for biopsy proven carcinoma breast
Who cannot join
- Immediate reconstruction
- Patient refusal to participate in study
About this study
Official title: Single vs. Double Drain in Modified Radical Mastectomy: A Randomized Control Trial
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Drain
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DrainDevice
Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain
| Study group | Role | What they receive |
|---|---|---|
| Single drain in modified radical mastectomy | Active comparator | Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain Receives: Device: Drain |
| Double drain in modified radical mastectomy | Active comparator | Post modified radical mastectomy with either one or two drains Intervention is use of single or double drain Receives: Device: Drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
seroma formation
fluid collection beneath the flap sufficient to cause patient discomfort and pain
Measured: 30 days post surgery
Secondary outcomes (5)
Duration of hospital stay,,
Measured: 30 days after surgery
wound infection
as described by center of disease control (CDC) criteria
Measured: 30 days after surgery
postoperative pain
measured on visual analogue scale (1 to 10) in first 24 hours after surgery.
Measured: 30 days after surgery
hematoma
blood collection under the flap
Measured: 30 days after surgery
flap necrosis
flap discoloration due to compromised blood supply of flap
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2015 (estimated)
- Study startJan 2013
- Primary completionNov 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memon Medical Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, salma khan, Memon Medical Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02411617
- Sponsor's protocol ID
- ERC:02
- Status last verified
- Apr 2015
- First submitted
- 27 Feb 2015
- Last updated
- 8 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Khan S, Khan M, Wasim A. Single vs. double drain in modified radical mastectomy: A randomized controlled trial. Turk J Surg. 2023 Jun 19;39(2):145-152. doi: 10.47717/turkjsurg.2023.5666. eCollection 2023 Jun.
PubMed 38026913
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single vs. Double Drain in Modified Radical Mastectomy: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT02411617
- Acronym / sponsor ID
- ERC:02
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Memon Medical InstituteUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Nov 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 8 Apr 2015 (estimated)
- 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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single drain in modified radical mastectomy | Active comparator | Device: DrainPost modified radical mastectomy with either one or two drains Intervention is use of single or double drain |
| Double drain in modified radical mastectomy | Active comparator | Device: DrainPost modified radical mastectomy with either one or two drains Intervention is use of single or double drain |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All female patients underwent MRM for biopsy proven carcinoma breast
Key exclusion criteria (2 listed)
- Immediate reconstruction
- Patient refusal to participate in study
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 |
|---|---|---|
| DrainPost modified radical mastectomy with either one or two drains Intervention is use of single or double drain | Device | Double drain in modified radical mastectomy, Single drain in modified radical mastectomy |
Primary outcome
seroma formation
Time frame: 30 days post surgery
fluid collection beneath the flap sufficient to cause patient discomfort and pain
5 secondary outcomes
Duration of hospital stay,,
Time frame: 30 days after surgery
wound infection
Time frame: 30 days after surgery
postoperative pain
Time frame: 30 days after surgery
hematoma
Time frame: 30 days after surgery
flap necrosis
Time frame: 30 days after surgery
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 8 Apr 2015.
- Derived from this study: PubMed 38026913Khan S, Khan M, Wasim A. Single vs. double drain in modified radical mastectomy: A randomized controlled trial. Turk J Surg. 2023 Jun 19;39(2):145-152. doi: 10.47717/turkjsurg.2023.5666. eCollection 2023 Jun.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Drain in people with Breast Cancer, run by Memon Medical Institute.
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 2 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 8 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
seroma formation (time frame: 30 days post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02411617, which also lists 1 linked publication.
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 8 Apr 2015; AzTrials last refreshed its copy on 29 Oct 2026.