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

Wound Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00576745
• Other study ID #: H-26298
• Status: Completed
• Phase: Phase 1
• First received: December 18, 2007
• Last updated: July 17, 2012
• Start date: September 2007
• Est. completion date: December 2010

Study information

• Verified date: July 2012
• Source: American Heart Association
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: December 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Wound Infection

Intervention

Procedure:
• Vicryl Suture
A 4-0 vicryl suture will be used to close the subcuticular layer

Device:
• 3M TM S Surgical Skin Closure System
These steri-strips will be applied to close the skin in this cohort of patients

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
American Heart Association

Country where clinical trial is conducted

United States, 

References & Publications (1)

Lazar HL, McCann J, Fitzgerald CA, Cabral HJ. Adhesive strips versus subcuticular suture for mediansternotomy wound closure. J Card Surg. 2011 Jul;26(4):344-7. doi: 10.1111/j.1540-8191.2011.01257.x. Epub 2011 May 9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of erythema		30 days following surgery	Yes
Secondary	Incidence of infection		30 days following surgery	Yes