Prevention of Capsular Contracture Using Trental and Vitamin E
Summary
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.
Description
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.
Study Design
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Prevention
Conditions
Capsular Contractures
Intervention
Trental
Location
Legacy Good Samaritan Medical Center
Portland
Oregon
United States
97210
Status
Recruiting
Source
Legacy Health System
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01082003
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Posterior Capsular Rupture, Ocular
A breach in the continuity of the posterior chamber of the eyeball.
Anterior Capsular Rupture, Ocular
A breach in the continuity of the ANTERIOR CHAMBER of the eyeball.
Implant Capsular Contracture
The shrinkage of the foreign body encapsulation scar tissue that forms around artificial implants imbedded in body tissues.
Adhesins, Escherichia Coli
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.
Hyalinosis, Systemic
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.
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PubMed Articles
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