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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00576745
First Posted: December 19, 2007
Last Update Posted: July 18, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Harold L. Lazar MD, Boston Medical Center
  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 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Of The 3M Surgical Skin Closure System To The Standard Vicryl Suture Closure Of Sternotomy Incisions

Further study details as provided by Harold L. Lazar MD, Boston Medical Center:

Primary Outcome Measures:
  • Incidence of erythema [ Time Frame: 30 days following surgery ]

Secondary Outcome Measures:
  • Incidence of infection [ Time Frame: 30 days following surgery ]

Enrollment: 36
Study Start Date: September 2007
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1 Vicryl Suture
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
Experimental: 2 Steri-Strips
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576745


Locations
United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
American Heart Association
Investigators
Principal Investigator: Harold L Lazar MD Boston Medical Center
  More Information

Publications:
Responsible Party: Harold L. Lazar MD, Professor of Cardiothoracic Surgery, Boston Medical Center
ClinicalTrials.gov Identifier: NCT00576745     History of Changes
Other Study ID Numbers: H-26298
First Submitted: December 18, 2007
First Posted: December 19, 2007
Last Update Posted: July 18, 2012
Last Verified: July 2012

Keywords provided by Harold L. Lazar MD, Boston Medical Center:
Sutures

Additional relevant MeSH terms:
Wound Infection
Infection