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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:
Information provided by (Responsible Party):
Harold L. Lazar MD, Boston Medical Center
ClinicalTrials.gov Identifier:
NCT00576745
First received: December 18, 2007
Last updated: July 17, 2012
Last verified: July 2012
History of Changes
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
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
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 ]

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

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

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

No publications provided

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
Study First Received: December 18, 2007
Last Updated: July 17, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by American Heart Association:
Sutures

Additional relevant MeSH terms:
Wound Infection
Infection
Wounds and Injuries

ClinicalTrials.gov processed this record on May 22, 2013