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Prevention of Capsular Contracture Using Trental and Vitamin E

2014-08-27 03:15:24 | 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

Published on BioPortfolio: 2014-08-27T03:15:24-0400

Clinical Trials [42 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

To evaluate the impact of capsular incisions on biochemical recurrence (BCR) and the potential risk factors of capsular incisions.

Aspen™ Ultrasound System and Aspen Rehabilitation Technique in the Treatment of Capsular Contracture

Purpose: The purpose of this investigation is to test the safety and effectiveness of the Aspen System™ and Aspen Rehabilitation Technique. The device is intended for the therapeutic tre...

Trental for the Treatment of Vertigo/Dizziness/Imbalance

Imbalance, dizziness and vertigo as a result of problems in the inner ear (vestibular dysfunction) are becoming increasingly more prevalent in Americans 40 years of age and older. The symp...

Electrothermal Arthroscopic Capsulorrhaphy (ETAC) and Open Inferior Capsular Shift in Patients With Shoulder Instability

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...

PubMed Articles [149 Associated PubMed Articles listed on BioPortfolio]

Does Implant Insertion with a Funnel Decrease Capsular Contracture? A Preliminary Report.

Capsular contracture remains a common and dreaded complication of breast augmentation. The etiology of capsular contracture is believed to be multi-factorial, and its causes may include biofilm format...

Traumatic Extra-capsular and Intra-capsular Floating Fat: Fat-fluid Levels of the Knee Revisited.

Floating fat is a sign of acute bone injury at the knee following trauma. The goal of this article is to review the etiology, patterns, and mimickers of extra-capsular and intra-capsular floating fat,...

Surgical treatment of upper extremity contractures in Emery-Dreifuss muscular dystrophy.

Emery-Dreifuss muscular dystrophy is a rare form of muscular dystrophy. In the present study we present two patients with Emery-Dreifuss muscular dystrophy and severe upper extremity contractures trea...

Effectiveness and Complications of Percutaneous Needle Tenotomy with a Large Needle for Muscle Contractures: A Cadaver Study.

Twenty-two percent of institutionalised elderly persons have muscle contractures. Contractures have important functional consequences, rendering hygiene and positioning in bed or in a chair difficult....

Pediatric Contractures in Burn Injury: A Burn Model System National Database Study.

Joint contractures are a major cause of morbidity and functional deficit. The incidence of postburn contractures and their associated risk factors in the pediatric population has not yet been reported...

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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