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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

Phase 1
Completed
Conditions
Wound Infection
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
Primary Outcome Measures
NameTimeMethod
Incidence of erythema30 days following surgery
Secondary Outcome Measures
NameTimeMethod
Incidence of infection30 days following surgery

Trial Locations

Locations (1)

Boston Medical Center

🇺🇸

Boston, Massachusetts, United States

Boston Medical Center
🇺🇸Boston, Massachusetts, United States

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