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

Sponsor

American Heart Association (Other)

Overall Status

Completed

CT.gov ID

NCT00576745

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Wound Infection	Procedure: Vicryl Suture Device: 3M TM S Surgical Skin Closure System	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2007

Actual Primary Completion Date :

Nov 1, 2010

Actual Study Completion Date :

Dec 1, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Vicryl Suture Patients will have their incision closed with vicryl suture	Procedure: Vicryl Suture A 4-0 vicryl suture will be used to close the subcuticular layer
Experimental: 2 Steri-Strips Patients will have their incisions closed with 3M Surgical-Strips	Device: 3M TM S Surgical Skin Closure System These steri-strips will be applied to close the skin in this cohort of patients

Arm

Intervention/Treatment

Active Comparator: 1 Vicryl Suture

Patients will have their incision closed with vicryl suture

Procedure: Vicryl Suture

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

Experimental: 2 Steri-Strips

Patients will have their incisions closed with 3M Surgical-Strips

Device: 3M TM S Surgical Skin Closure System

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

Outcome Measures

Primary Outcome Measures

Incidence of erythema [30 days following surgery]

Secondary Outcome Measures

Incidence of infection [30 days following surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Boston Medical Center	Boston	Massachusetts	United States	02118

Sponsors and Collaborators

American Heart Association

Investigators

Principal Investigator: Harold L Lazar MD, Boston Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Harold L. Lazar MD, Professor of Cardiothoracic Surgery, Boston Medical Center

ClinicalTrials.gov Identifier:

NCT00576745

Other Study ID Numbers:

H-26298

First Posted:

Dec 19, 2007

Last Update Posted:

Jul 18, 2012

Last Verified:

Jul 1, 2012

Keywords provided by Harold L. Lazar MD, Professor of Cardiothoracic Surgery, Boston Medical Center

Sutures

Additional relevant MeSH terms:

Wound Infection

Study Results

No Results Posted as of Jul 18, 2012