What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Surgery
What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Oncologic Surgery to Reduce Early Wound Complications
University of Alberta
105 participants
Jun 26, 2023
INTERVENTIONAL
Conditions
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.
Eligibility
Inclusion Criteria4
- Female
- \> 18 years of age
- Previous breast surgery and ipsilateral breast irradiation
- Requiring repeat breast surgery
Exclusion Criteria10
- 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
Interventions
Oral Antibiotic - used to treat post operative wound infections.
Negative pressure wound VAC placed on incision post operatively.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05823467