What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Surgery (NCT05823467) | Clinical Trial Compass
TerminatedNot Applicable
What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Surgery
Stopped: Logistical Issues
Canada4 participantsStarted 2023-06-26
Plain-language summary
This study will look at whether females who have previously had breast surgery and radiation and are undergoing repeat breast surgery require any post operative interventions. The reason the investigators are conducting this study is because females who have undergone breast radiation are at higher risk of wound complications following breast surgery. The investigators will randomize recruited female participants into three arms, one which is post operative antibiotics for one week, one which is a wound VAC, and one which is no intervention. The investigators goal is to identify whether these patients will require any postoperative interventions.
Who can participate
Age range
18 Years – 99 Years
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
* \> 18 years of age
* Previous breast surgery and ipsilateral breast irradiation
* Requiring repeat breast surgery
Exclusion Criteria:
* Male
* \<18 years of age,
* Currently on antibiotic therapy for other indications
* Known hypersensitivity to trimethoprim or sulfonamides,
* History of drug-induced immune thrombocytopenia with use of trimethoprim and/or sulfonamides
* Documented megaloblastic anemia due to folate deficiency
* Currently pregnant or breastfeeding, and
* Marked hepatic damage
* Severe renal insufficiency
* Severe sensitivity or allergy to silicone adhesive
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.
What they're measuring
1
Rate of Wound Complication
Timeframe: Post operative day 14 during follow up visit