What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Oncologic Surgery to Reduce Early Wound Complications

22-0241

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.

2023-06-26

2025-06-01

2025-12-31

Recruiting

105

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

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This study will randomize patients to three arms - patients will either be randomized to post operative antibiotic arm (1 week), post operative wound VAC arm (1 week), or no intervention.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 105, 'type': 'ESTIMATED'}}

2023-06-29