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Completed

NCT Number: NCT00576745

A Comparison Of The 3M TM S Surgical Skin Closure System To The Standard Vicryl Suture Closure of Sternotomy Incisions During Cardiac Surgery

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.

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Key information

Conditions

Wound Infection Infections

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Boston Medical Center

Boston, Massachusetts, 02118, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vicryl Suture

Procedure

A 4-0 vicryl suture will be used to close the subcuticular layer

3M TM S Surgical Skin Closure System

Device

These steri-strips will be applied to close the skin in this cohort of patients

Primary outcomes

  1. Incidence of erythema

    Time frame: 30 days following surgery

Secondary outcomes

  1. Incidence of infection

    Time frame: 30 days following surgery

Sponsors and collaborators

Lead sponsor

American Heart Association

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2010
Study completion
2010
First posted
Dec 19, 2007
Registry last updated
Jul 18, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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