Advertisement

Topics

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 [64 Associated Clinical Trials listed on BioPortfolio]

Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular Resection Versus Capsular Flap Retention

Direct Anterior Approach (DAA) for Total Hip Arthroplasty (THA): Capsular resection versus capsular flap retention. Prospective study design comparing clinical data in randomized THA pati...

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...

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...

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...

PubMed Articles [122 Associated PubMed Articles listed on BioPortfolio]

Bacterial biofilm associated with a case of capsular contracture.

Capsular contracture is one of the most common complications of implant-based breast augmentation. Despite its prevalence, the etiology of capsular contracture remains controversial although the surfa...

What Are the Effects of Capsular Plication on Translational Laxity of the Glenohumeral Joint: A Study in Cadaveric Shoulders.

Surgical treatment for shoulder instability generally involves labral repair with a capsular plication or imbrication. Good results are reported in both open and arthroscopic procedures, but there is ...

Gait analysis of patients with continuous proximal sciatic nerve blockade in flexion contractures after primary total knee arthroplasty.

The main objective of total knee arthroplasty is to relieve pain, restore normal knee function, and improve gait stability. Significant flexion contractures can severely impair function after surgery....

Muscle contractures in patients with cerebral palsy and acquired brain injury are associated with extracellular matrix expansion, pro-inflammatory gene expression, and reduced rRNA synthesis.

Children with cerebral palsy (CP) and acquired brain injury (ABI) commonly develop muscle contractures with advancing age. An underlying growth defect contributing to skeletal muscle contracture forma...

In Search of a Murine Model of Radiation-Induced Periprosthetic Capsular Fibrosis.

Capsular contracture after breast reconstruction is a morbid complication, occurring in 30.0% to 47.5% of patients undergoing postoperative radiotherapy. Although it is well known that radiation incre...

Medical and Biotech [MESH] Definitions

Surgical incision on the FASCIA. It is used to decompress compartment pressure (e.g. in COMPARTMENT SYNDROMES; circumferential burns and extremity injuries) or to release contractures (e.g. in DUPUYTREN'S CONTRACTURE).

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.

More From BioPortfolio on "Prevention of Capsular Contracture Using Trental and Vitamin E"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...

Breast Cancer
Track and monitor developments in breast cancer research and commercial development.  Follow the tabs above to read the latest global news, research, clinical trials on breast cancer and follow companies active in the development of breast cancer tr...


Searches Linking to this Trial