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| Sponsored by: |
American Heart Association |
| Information provided by: | American Heart Association |
| ClinicalTrials.gov Identifier: | NCT00576745 |
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 I |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | Comparison Of The 3M Surgical Skin Closure System To The Standard Vicryl Suture Closure Of Sternotomy Incisions |
| Estimated Enrollment: | 60 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | December 2008 |
| Arms | Assigned Interventions |
|
1 Vicryl Suture: Active Comparator
Patients will have their incision closed with vicryl suture
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Procedure: Vicryl Suture
A 4-0 vicryl suture will be used to close the subcuticular layer
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2 Steri-Strips: Experimental
Patients will have their incisions closed with 3M Surgical-Strips
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Device: 3M TM S Surgical Skin Closure System
These steri-strips will be applied to close the skin in this cohort of patients
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Eligibility
| Ages Eligible for Study: | 18 Years to 90 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Patients with:
Contacts and Locations| Contact: Harold L Lazar, MD | 617-638-7352 | harold.lazar@bmc.org |
| Contact: Carmel Fitzgerald, RN | 617-638-7348 | carmel.fitzgerald@bmc.org |
| United States, Massachusetts | |||||
| Boston Medical Center | Recruiting | ||||
| Boston, Massachusetts, United States, 02118 | |||||
| Contact: Harold L Lazar, MD 617-638-7350 harold.lazar@bmc.org | |||||
| Principal Investigator: Harold L Lazar, MD | |||||
| American Heart Association |
| Principal Investigator: | Harold L Lazar MD | Boston Medical Center |
More Information
| Responsible Party: | Boston Medical Center ( Harold L. Lazar MD ) |
| Study ID Numbers: | H-26298 |
| First Received: | December 18, 2007 |
| Last Updated: | December 26, 2007 |
| ClinicalTrials.gov Identifier: | NCT00576745 |
| Health Authority: | United States: Institutional Review Board |
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