Prevention of Capsular Contracture Using Trental and Vitamin E

01:22 EDT 28th August 2014 | BioPortfolio

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)

View Results

Links

Clinical Trials [31 Associated Clinical Trials listed on BioPortfolio]

Trental & Vitamin E for Radiation-Induced Fibrosis

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...

A Capsular Incision and Biochemical Recurrence After Radical Perineal Prostatectomy

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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...

A Comparative Study of the Effectiveness of Treatment of Contractures With Mechanically Applied Stretch and Heat.

This study is looking at new ways to stretch knee contractures in children with cerebral palsy using a specially designed splint.

Clinical Evaluation of the Use of Sealed Capsule Irrigation With Sodium Chloride During Pediatric Cataract Surgery and IOL Implantation

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...

PubMed Articles [157 Associated PubMed Articles listed on BioPortfolio]

A study to evaluate whether CTR increases refractive unpredictability between predicted and actual IOL position.

The surgical management of cataract associated with extensive zonular loss presents a challenge for ophthalmic surgeon. Capsular Tension Ring (CTR) is commonly being used to stabilize the capsular bag...

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The role of capsular repair in the arthroscopic treatment of femoroacetabular impingement remains poorly defined. Some surgeons rarely repair the capsule, whereas others perform repairs routinely. The...

Determination of native capsular polysaccharide structures of Streptococcus pneumoniae serotypes 39, 42, and 47F and comparison to genetically or serologically related strains.

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...

Hand Surgery for Dystrophic Epidermolysis Bullosa.

Epidermolysis bullosa (EB) is a group of inherited, mechanobullous disorders caused by mutations in various structural proteins in the skin. The manifestation of these disorders in the hand is of digi...

Traumatic Rupture of a Hydrogel-filled Breast Implant - A Case for the Employer's Liability Insurance Association?

Today textured breast implants for augmentation and reconstruction are commonly used to reduce the incidence of capsular contractures. Despite modified surfaces, capsular contracture may occur as resu...

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.

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