Evaluating post-operative care for women with irradiated breasts undergoing repeat surgery
What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Oncologic Surgery to Reduce Early Wound Complications
This study is testing if giving antibiotics or using a special wound device after repeat breast surgery helps women who have had radiation therapy avoid complications.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 105 (estimated) |
| Ages | 18 Years to 99 Years |
| Sex | Female |
| Sponsor | University of Alberta Academic / other |
| Drugs / interventions | radiation |
| Locations | 2 sites (Edmonton, Alberta and 1 other locations) |
| Trial ID | NCT05823467 on ClinicalTrials.gov |
What this trial studies
This study investigates the need for post-operative interventions in women who have previously undergone breast surgery and radiation and are now facing repeat surgery. Participants will be randomized into three groups: one receiving post-operative antibiotics, another using a wound VAC, and a control group with no intervention. The goal is to determine if these interventions can reduce the risk of wound complications, which are notably higher in patients with prior radiation therapy. The study aims to fill the gap in existing guidelines regarding post-operative care for this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are females over 18 years old who have had previous breast surgery and radiation and require repeat breast surgery.
Not a fit: Patients who are male, under 18 years old, or have specific medical conditions or allergies that exclude them from the study may not benefit.
Why it matters
Potential benefit: If successful, this study could lead to improved post-operative outcomes and reduced complications for women undergoing repeat breast surgery after radiation.
How similar studies have performed: Previous studies have shown promising results with similar approaches, indicating potential for significant improvements in post-operative care for this patient group.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Edmonton, Alberta and 1 other locations
- Meadowlark Health Centre — Edmonton, Alberta, Canada (Recruiting)
- St Thomas Surgical Clinic — St. Albert, Alberta, Canada (Recruiting)
Study contacts
- Principal investigator: Azadeh Rajaee, MD — University of Alberta
- Study coordinator: Mahmoud, BHSc
- Email: sheharza@ualberta.ca
- Phone: 780-486-5030
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.