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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

NCT ID: NCT00576745

Last Updated: 2012-07-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-09-30

Study Completion Date

2010-12-31

Brief Summary

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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

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Conditions

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Wound Infection

Keywords

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Sutures

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1 Vicryl Suture

Patients will have their incision closed with vicryl suture

Group Type ACTIVE_COMPARATOR

Vicryl Suture

Intervention Type PROCEDURE

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

2 Steri-Strips

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

Group Type EXPERIMENTAL

3M TM S Surgical Skin Closure System

Intervention Type DEVICE

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

Interventions

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Vicryl Suture

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

Intervention Type PROCEDURE

3M TM S Surgical Skin Closure System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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American Heart Association

OTHER

Sponsor Role lead

Responsible Party

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Harold L. Lazar MD

Professor of Cardiothoracic Surgery

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Harold L Lazar MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

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Boston Medical Center

Boston, Massachusetts, United States

Site Status

Countries

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United States

References

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Lazar HL, McCann J, Fitzgerald CA, Cabral HJ. Adhesive strips versus subcuticular suture for mediansternotomy wound closure. J Card Surg. 2011 Jul;26(4):344-7. doi: 10.1111/j.1540-8191.2011.01257.x. Epub 2011 May 9.

Reference Type RESULT
PMID: 21554389 (View on PubMed)

Other Identifiers

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H-26298

Identifier Type: -

Identifier Source: org_study_id