Clinical trial · Interventional
What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Surgery
What is Optimal Post-operative Prophylactic Therapy in Irradiated Breasts Undergoing Repeat Oncologic Surgery to Reduce Early Wound Complications
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Logistical Issues
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ciNPT dressing | Device | — | UNRESOLVED |
| TMP-SMX DS | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Post operative Antibiotic
- description
- Patients in this arm will have a prescription for one week or post operative antibiotic ( 7-day course of TMP-SMX DS )
- interventionNames
- Drug: TMP-SMX DS
- type
- EXPERIMENTAL
- label
- Post operative Wound VAC
- description
- Patient will have a 7-day application of ciNPT dressing post operatively.
- interventionNames
- Device: ciNPT dressing
- type
- NO_INTERVENTION
- label
- No Intervention
- description
- Patient will be treated as standard of care which is no intervention.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
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
References
Publications (4)
- BACKGROUNDEdwards 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. PMID 25138078
- BACKGROUNDFerrando 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. PMID 30276035
- BACKGROUNDOlsen 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. PMID 25358666
- BACKGROUNDRuvalcaba-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. PMID 16319989