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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00576745
Other study ID # H-26298
Secondary ID
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


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
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