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Clinical Trials/NCT00576745
NCT00576745
Completed
Phase 1

Comparison Of The 3M Surgical Skin Closure System To The Standard Vicryl Suture Closure Of Sternotomy Incisions

American Heart Association1 site in 1 country36 target enrollmentStarted: September 2007Last updated:
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ConditionsWound Infection

Overview

Phase
Phase 1
Status
Completed
Enrollment
36
Locations
1
Primary Endpoint
Incidence of erythema
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 90 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Incidence of erythema

Time Frame: 30 days following surgery

Secondary Outcomes

  • Incidence of infection(30 days following surgery)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Harold L. Lazar MD

Professor of Cardiothoracic Surgery

Boston Medical Center

Study Sites (1)

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