Back to resultsA Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery
Primary Purpose
Wound Infection
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Vicryl Suture
3M TM S Surgical Skin Closure System
Sponsored by
About this trial
This is an interventional treatment trial for Wound Infection focused on measuring Sutures
Eligibility 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
Sites / Locations
- Boston Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
1 Vicryl Suture
2 Steri-Strips
Arm Description
Patients will have their incision closed with vicryl suture
Patients will have their incisions closed with 3M Surgical-Strips
Outcomes
Primary Outcome Measures
Incidence of erythema
Secondary Outcome Measures
Incidence of infection
Full Information
NCT ID
NCT00576745
First Posted
December 18, 2007
Last Updated
July 17, 2012
Sponsor
American Heart Association
1. Study Identification
Unique Protocol Identification Number
NCT00576745
Brief Title
A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery
Official Title
Comparison Of The 3M Surgical Skin Closure System To The Standard Vicryl Suture Closure Of Sternotomy Incisions
Study Type
Interventional
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
December 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
American Heart Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wound Infection
Keywords
Sutures
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1 Vicryl Suture
Arm Type
Active Comparator
Arm Description
Patients will have their incision closed with vicryl suture
Arm Title
2 Steri-Strips
Arm Type
Experimental
Arm Description
Patients will have their incisions closed with 3M Surgical-Strips
Intervention Type
Procedure
Intervention Name(s)
Vicryl Suture
Intervention Description
A 4-0 vicryl suture will be used to close the subcuticular layer
Intervention Type
Device
Intervention Name(s)
3M TM S Surgical Skin Closure System
Intervention Description
These steri-strips will be applied to close the skin in this cohort of patients
Primary Outcome Measure Information:
Title
Incidence of erythema
Time Frame
30 days following surgery
Secondary Outcome Measure Information:
Title
Incidence of infection
Time Frame
30 days following surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harold L Lazar MD
Organizational Affiliation
Boston Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
21554389
Citation
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.
Results Reference
result
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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
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