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Rapid Sternal Closure System (TALON)

2014-08-27 03:32:06 | BioPortfolio

Summary

The primary objective is to establish if the Rapid Sternal Closure System improves early postoperative recovery as manifested by decreased pain and improved pulmonary function.

Secondary objectives include evaluation of Rapid Sternal Closure System with regard to SWCs (surgically treated sternal wound infection and sternal instability/non-union) as outlined in the protocol.

For a given study endpoint, the null hypothesis will be no difference between the RSCS group and the control group. The alternative hypothesis will be a difference between 2 groups. The statistical objective of this study is to reject the null hypothesis in favor of the alternative hypothesis.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Conditions

Sternal Wound Infection

Intervention

Rapid Sternal Closure System

Location

Duke University Medical Center
Durham
North Carolina
United States
27710

Status

Completed

Source

Duke University

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:32:06-0400

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Sternal Closure With SternaLock 360: First in Man Study

The SternaLock 360 Sternal Closure Device combines the techniques of rigid fixation with a cerclage material into a single sternal closure system. The cerclage material serves to facilitat...

Improving Sternal Healing After Cardiac Surgery: Sternal Wire vs ZIPFIX

The objective of this study is to determine whether sternal reconstruction using the ZIPFIX system compared to standard wire cerclage could improve bone healing, patient function, and decr...

Effects of Platelet Rich Fibrin (PRF) in Treatment of Non-healing Sternum Wound After Open-heart Surgery

Sternal wound and there complication such as infection, Bruising and scar formation are known as major complication cardiac surgery with a high mortality rate up to 50%. Several approaches...

Montage-Enhanced Sternal Closure

Post-operative recovery after cardiac surgery is influenced by early sternal bone stability. Traditional sternal closure of median sternotomy usually entails the use of 6-10 stainless stee...

Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections

The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cum...

PubMed Articles [19519 Associated PubMed Articles listed on BioPortfolio]

A Simple Modification of the Conventional Figure-of-Eight Sternal Closure Technique.

To describe a new technique of sternal closure, modified from the conventional figure-of-eight approach, which can provide a secure closure and prevent sternal complications.

A Technique for 360-Degree Rigid Sternal Fixation with Sternal Plates and Wire Cerclage.

Sternal instability after cardiac surgery can lead to poor bony healing, as well as deep sternal wound infections and mediastinitis. Rigid plate fixation is associated with greater stability and fewer...

Delayed Sternal Closure in Congenital Heart Surgery: A Risk-Benefit Analysis.

Delayed sternal closure commonly is used after pediatric cardiac surgery. Its benefits include relieving cardiac compression and stabilizing postoperative critically ill patients.

Chronic Serratia marcescens sternal infection presenting 13 years after coronary artery surgery.

Serratia marcescens is a facultative anaerobic bacillus that very rarely causes sternal infections. We describe a sternal abscess resulting from chronic S. marcescens infection that presented 13 years...

Reconstruction of a deep sternal wound with exposed pericardium using an IMAP propeller flap: A case report.

The results of this case suggest that the IMAP propeller flap may be a viable and safe option for deep sternal wound reconstruction with minimal donor-site morbidity.

Medical and Biotech [MESH] Definitions

A syndrome which is characterized by symbrachydactyly and aplasia of the sternal head of pectoralis major.

The application of a vacuum across the surface of a wound through a foam dressing cut to fit the wound. This removes wound exudates, reduces build-up of inflammatory mediators, and increases the flow of nutrients to the wound thus promoting healing.

Methods to repair breaks in tissue caused by trauma or to close surgical incisions.

A spasm of the diaphragm that causes a sudden inhalation followed by rapid closure of the glottis which produces a sound.

A method of stopping internal bleeding or blood flow, or the closure of a wound or body cavity, achieved by applying pressure or introducing an absorbent liquid, gel, or tampon.

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