Active Drainage vs. Passive Drainage in MRM (NCT07621575) | Clinical Trial Compass
CompletedNot Applicable
Active Drainage vs. Passive Drainage in MRM
Egypt157 participantsStarted 2024-05-30
Plain-language 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. 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).
Who can participate
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.