A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery
Phase 1
Completed
- Conditions
- Wound Infection
- Interventions
- Procedure: Vicryl SutureDevice: 3M TM S Surgical Skin Closure System
- Registration Number
- NCT00576745
- Lead Sponsor
- American Heart Association
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 36
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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Vicryl Suture Vicryl Suture Patients will have their incision closed with vicryl suture 2 Steri-Strips 3M TM S Surgical Skin Closure System Patients will have their incisions closed with 3M Surgical-Strips
- Primary Outcome Measures
Name Time Method Incidence of erythema 30 days following surgery
- Secondary Outcome Measures
Name Time Method Incidence of infection 30 days following surgery
Trial Locations
- Locations (1)
Boston Medical Center
🇺🇸Boston, Massachusetts, United States