drugset / Trial / NCT01082003
Prevention of Capsular Contracture Using Trental and Vitamin E
Non-randomizedSingle-groupOpen-labelPrevention
Summary
The main purpose of this research study is to determine if the use of Trental and Vitamin E will decrease the incidence and severity of contractures (shrinking and or hardening of tissue surrounding the implant) associated with breast implant reconstruction following radiation treatment. Another goal is to find out the impact that Trental and Vitamin E have on implant loss or need for surgical intervention in the setting of chest wall radiation after reconstruction. In addition, the investigators want to evaluate the patient's sense of well being and quality of life.
Timeline
- Start
- 2009-10
- Primary completion
- 2013-08
- Completion
- 2014-06
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Pentoxifylline | Small molecule | 400 mg | — |
| Subject | Vitamin E | Other / unclassified | 400 iu | Oral |
Indications
No indication recorded.