A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery - Tabular View

Tracking Information

First Received Date ^ICMJE

December 18, 2007

Last Updated Date

December 26, 2007

Start Date ^ICMJE

September 2007

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Incidence of erythema [ Time Frame: 30 days following surgery ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00576745 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence of infection [ Time Frame: 30 days following surgery ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery

Official Title ^ICMJE

Comparison Of The 3M Surgical Skin Closure System To The Standard Vicryl Suture Closure Of Sternotomy Incisions

Brief Summary

Following closure of surgical incisions, wounds may develop redness, swelling, and drainage which may result in increased pain and infection. This study will test to hypothesis that using the 3M TM S Surgical Skin Closure System will reduce the incidence of pain, redness, swelling, and infections in a group of patients undergoing a mediastinotomy incision used for open heart surgical procedures.

Detailed Description

Study Phase

Phase I

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Wound Infection

Intervention ^ICMJE

Procedure: Vicryl Suture
Device: 3M TM S Surgical Skin Closure System

Study Arms / Comparison Groups

Active Comparator: Patients will have their incision closed with vicryl suture
Experimental: Patients will have their incisions closed with 3M Surgical-Strips

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

December 2008

Primary Completion Date

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Patients undergoing mediastinotomy for cardiac surgical procedures

Exclusion Criteria:

Patients with:

Allergies to skin adhesives
Known keloid formation
Prior sternotomies
Conditions making them not candidates for vicryl skin closure

Gender

Both

Ages

18 Years to 90 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Harold L Lazar, MD	617-638-7352	harold.lazar@bmc.org
Contact: Carmel Fitzgerald, RN	617-638-7348	carmel.fitzgerald@bmc.org

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00576745

Responsible Party

Harold L. Lazar MD, Boston Medical Center

Study ID Numbers ^ICMJE

H-26298

Study Sponsor ^ICMJE

American Heart Association

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Harold L Lazar MD

Boston Medical Center

Information Provided By

American Heart Association

Verification Date

September 2007

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP