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

American Heart Association (AHA)

Status and phase: Completed; Phase 1

Conditions: Wound Infection

Treatments: Procedure: Vicryl Suture; Device: 3M TM S Surgical Skin Closure System

Study type: Interventional

Funder types: Other

Identifiers

NCT00576745

H-26298

Details and patient eligibility

About

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.

Enrollment: 36 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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36 participants in 2 patient groups

1 Vicryl Suture

Active Comparator group

Description:

Patients will have their incision closed with vicryl suture

Treatment:

Procedure: Vicryl Suture

2 Steri-Strips

Experimental group

Description:

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

Treatment:

Device: 3M TM S Surgical Skin Closure System