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

This study is currently recruiting participants.

Verified by American Heart Association, September 2007

First Received: December 18, 2007 Last Updated: December 26, 2007 History of Changes

Sponsored by:	American Heart Association
Information provided by:	American Heart Association
ClinicalTrials.gov Identifier:	NCT00576745

Purpose

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.

Condition	Intervention	Phase
Wound Infection	Procedure: Vicryl Suture Device: 3M TM S Surgical Skin Closure System	Phase I

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	Comparison Of The 3M Surgical Skin Closure System To The Standard Vicryl Suture Closure Of Sternotomy Incisions

Resource links provided by NLM:

MedlinePlus related topics: Heart Surgery Surgery

U.S. FDA Resources

Further study details as provided by American Heart Association:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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

Estimated Enrollment:	60
Study Start Date:	September 2007
Estimated Study Completion Date:	December 2008

Arms	Assigned Interventions
1 Vicryl Suture: Active Comparator Patients will have their incision closed with vicryl suture	Procedure: Vicryl Suture A 4-0 vicryl suture will be used to close the subcuticular layer
2 Steri-Strips: Experimental Patients will have their incisions closed with 3M Surgical-Strips	Device: 3M TM S Surgical Skin Closure System These steri-strips will be applied to close the skin in this cohort of patients

Eligibility

Ages Eligible for Study:	18 Years to 90 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00576745

Contacts

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

Locations

United States, Massachusetts
Boston Medical Center	Recruiting
Boston, Massachusetts, United States, 02118
Contact: Harold L Lazar, MD 617-638-7350 harold.lazar@bmc.org
Principal Investigator: Harold L Lazar, MD

Sponsors and Collaborators

American Heart Association

Investigators

Principal Investigator:

Harold L Lazar MD

Boston Medical Center

More Information

No publications provided

Responsible Party:	Boston Medical Center ( Harold L. Lazar MD )
Study ID Numbers:	H-26298
Study First Received:	December 18, 2007
Last Updated:	December 26, 2007
ClinicalTrials.gov Identifier:	NCT00576745 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by American Heart Association:

Sutures

Study placed in the following topic categories:

Wounds and Injuries
Disorders of Environmental Origin
Wound Infection

Additional relevant MeSH terms:

Wounds and Injuries
Disorders of Environmental Origin
Infection
Wound Infection

ClinicalTrials.gov processed this record on July 06, 2009