What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Surgery

What this study is about

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 join (things the study team will check)

✅ You may be able to join if…

• Female
• > 18 years of age
• Previous breast surgery and ipsilateral breast irradiation
• Requiring repeat breast surgery

🚫 You may not be able to join if…

• 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

Where this trial is running

• Meadowlark Health Centre, Edmonton, Alberta, Canada
• St Thomas Surgical Clinic, St. Albert, Alberta, Canada

Who to contact

Mahmoud, BHSc · 780-486-5030 · sheharza@ualberta.ca

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT05823467.