drugset / Trial / NCT05823467
What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Surgery
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2023-06-26
- Primary completion
- 2026-07-01
- Completion
- 2026-07-01
Publications
- Background 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.
- Background 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.
- Background 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.
- Background 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | trimethoprim-sulfamethoxazole | Unknown | — | Oral |