Prevention of Capsular Contracture Using Trental and Vitamin E
The main purpose of this research study is to determine if the use of Trental and Vitamin E compared to Placebo (an inactive substance) 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 compared to Placebo may 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.
This is a single center trial conducted through Legacy Health System. Sixty-two patients from Legacy Good Samaritan Hospital in Portland, Oregon will be enrolled. Study subjects will be "randomized", like the flip of a coin, into one of the two study groups to receive either Trental and Vitamin E or Placebo for a six-month period. You will be required to have a total of 6 study visits at Legacy Good Samaritan Hospital. Your participation in this study will begin within 2 weeks of completing radiation treatment and last a total of 18 months. You will continue to receive the standard treatment for your breast cancer while on this study
Visual and clinical assessment of your chest area to include photographs is required in order to meet the primary goal of the study.
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Legacy Good Samaritan Medical Center
Legacy Health System
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01082003
- Information obtained from ClinicalTrials.gov on July 15, 2010
This study seeks to determine if a combination of Trental and Vitamin E prevents the development of radiation fibrosis in women treated with radiation for the definitive management of thei...
To evaluate the impact of capsular incisions on biochemical recurrence (BCR) and the potential risk factors of capsular incisions.
This trial will compare the effectiveness of electrothermal arthroscopic capsulorrhaphy (ETAC) to the current reference standard procedure, open inferior capsular shift (ICS), for the trea...
This study is looking at new ways to stretch knee contractures in children with cerebral palsy using a specially designed splint.
This study involves using both a device that seals the capsular bag (where the lens is located) allowing safer irrigation of the capsular bag and sodium chloride to irrigate the capsular b...
Joint contractures are a common problem for older, frail people, particularly in rehabilitation, nursing home and homecare settings. Joint contractures are underreported and sparsely empirically inves...
The diversity of capsular polysaccharides of the bacterial pathogen Streptococcus pneumoniae leads to at least 91 different serotypes. While the genetic loci for capsular biosynthesis have been charac...
The purpose of this study was to develop a novel method to quantify hip capsular volume in patients undergoing hip arthroscopic surgery, utilizing magnetic resonance arthrogram (MRA) and to determine ...
Posterior capsular rupture (PCR) and vitreous loss are inevitable complications encountered in cataract surgery across all levels of surgical experience and in spite of technological advances to impro...
To discuss capsular tension devices and recent evidence regarding their use.
Medical and Biotech [MESH] Definitions
A breach in the continuity of the posterior chamber of the eyeball.
A breach in the continuity of the ANTERIOR CHAMBER of the eyeball.
The shrinkage of the foreign body encapsulation scar tissue that forms around artificial implants imbedded in body tissues.
Thin, filamentous protein structures, including proteinaceous capsular antigens (fimbrial antigens), that mediate adhesion of E. coli to surfaces and play a role in pathogenesis. They have a high affinity for various epithelial cells.
Autosomal recessive disorder characterized by HYALINE deposition in the skin, bone, gastrointestinal tract, muscles and glands; multiple subcutaneous skin nodules; GINGIVAL HYPERTROPHY; and joint CONTRACTURES. It is comprised of two allelic disorders: infantile systemic hyalinosis and juvenile hyaline fibromatosis. Mutations in the capillary morphogenesis protein-2 are associated with the disorder.