Post-Operative Care for Breast Surgery After Radiation
Trial Summary
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are currently on antibiotic therapy for other reasons, you cannot participate in this trial.
What data supports the effectiveness of the treatment ciNPT dressing, Negative Pressure Wound Therapy (NPWT) dressing, and Vacuum-Assisted Closure (VAC) dressing for post-operative care in breast surgery after radiation?
Research shows that negative pressure wound therapy (NPWT) can help promote healing in complex wounds, especially in patients with delayed healing due to chemotherapy and radiation. However, studies specifically on closed-incision negative pressure therapy (ciNPT) in oncological breast surgery have not shown a significant reduction in surgical site infections compared to standard dressings.12345
Is trimethoprim-sulfamethoxazole (TMP-SMX) generally safe for humans?
Trimethoprim-sulfamethoxazole (TMP-SMX) is generally considered safe for humans, but it can cause adverse effects in some cases. Studies have shown that while it is well-tolerated by many, some people may experience side effects like thrombocytopenia (low platelet count) and allergic reactions, especially when used with other medications.678910
How does the treatment for post-operative care after breast surgery differ from other treatments?
What is the purpose of this trial?
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.
Research Team
Azadeh Rajaee, MD
Principal Investigator
University of Alberta
Eligibility Criteria
This trial is for women over 18 who have had breast surgery and radiation, and now need another breast surgery. They can't join if they're pregnant, breastfeeding, allergic to silicone adhesive or certain antibiotics, have severe liver or kidney issues, are under 18, male, or currently on other antibiotics.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized into three arms: post-operative antibiotics for one week, wound VAC for one week, or no intervention
Follow-up
Participants are monitored for wound complications and adverse effects of interventions
Extended Follow-up
Participants are monitored for any repeat hospital visits or extended complications
Treatment Details
Interventions
- ciNPT dressing
- TMP-SMX DS
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Alberta
Lead Sponsor