Breast Cancer Clinical Trial
Official title:
What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Oncologic Surgery to Reduce Early Wound Complications
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.
Status | Recruiting |
Enrollment | 105 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 1, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 99 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Canada | Meadowlark Health Centre | Edmonton | Alberta |
Canada | St Thomas Surgical Clinic | St. Albert | Alberta |
Lead Sponsor | Collaborator |
---|---|
University of Alberta |
Canada,
Edwards BL, Stukenborg GJ, Brenin DR, Schroen AT. Use of prophylactic postoperative antibiotics during surgical drain presence following mastectomy. Ann Surg Oncol. 2014 Oct;21(10):3249-55. doi: 10.1245/s10434-014-3960-7. Epub 2014 Aug 20. — View Citation
Ferrando PM, Ala A, Bussone R, Bergamasco L, Actis Perinetti F, Malan F. Closed Incision Negative Pressure Therapy in Oncological Breast Surgery: Comparison with Standard Care Dressings. Plast Reconstr Surg Glob Open. 2018 Jun 15;6(6):e1732. doi: 10.1097/GOX.0000000000001732. eCollection 2018 Jun. — View Citation
Olsen MA, Nickel KB, Margenthaler JA, Wallace AE, Mines D, Miller JP, Fraser VJ, Warren DK. Increased Risk of Surgical Site Infection Among Breast-Conserving Surgery Re-excisions. Ann Surg Oncol. 2015;22(6):2003-9. doi: 10.1245/s10434-014-4200-x. Epub 2014 Oct 31. — View Citation
Ruvalcaba-Limon E, Robles-Vidal C, Poitevin-Chacon A, Chavez-Macgregor M, Gamboa-Vignolle C, Vilar-Compte D. Complications after breast cancer surgery in patients treated with concomitant preoperative chemoradiation: A case-control analysis. Breast Cancer Res Treat. 2006 Jan;95(2):147-52. doi: 10.1007/s10549-005-9058-y. Epub 2005 Dec 1. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Rate of Wound Complication | Assessment of rate of Wound complication with each intervention arm, immediately after intervention | Post operative day 14 during follow up visit | |
Secondary | Adverse effects from intervention arm | Will assess for any adverse reaction from each intervention as well as repeat hospital visit within 30 days (after the procedure and intervention) | post procedure from post operative day 1 - post operative day 30 |
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