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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

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

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00576745
Enrollment
36
Registered
2007-12-19
Start date
2007-09-30
Completion date
2010-12-31
Last updated
2012-07-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Wound Infection

Keywords

Sutures

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.

Interventions

PROCEDUREVicryl Suture

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

DEVICE3M TM S Surgical Skin Closure System

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

Sponsors

American Heart Association
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
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

Design outcomes

Primary

MeasureTime frame
Incidence of erythema30 days following surgery

Secondary

MeasureTime frame
Incidence of infection30 days following surgery

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026