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CompletedNCT00576745Updated Jul 18, 2012

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

A Phase 1 interventional study of Vicryl Suture and 3M TM S Surgical Skin Closure System in Wound Infection, sponsored by American Heart Association. Completed at 1 site in United States. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2012-07-18.

Sponsored by American Heart Association · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
36
Allocation
Randomized
Ages
18 Years to 90 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Wound Infection

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Keywords

  • Sutures
03

In context

Wound Infection

388 studies on the registry are indexed under Wound Infection; 40 are open to participants now.

This study's enrollment of 36 is below the median of 150 across 301 interventional studies indexed under Wound Infection.

Browse Wound Infection studies →

Lead sponsor

American Heart Association is the lead sponsor of 13 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients undergoing mediastinotomy for cardiac surgical procedures

Exclusion criteria

Exclusion Criteria:

Patients with:

  • Allergies to skin adhesives
  • Known keloid formation
  • Prior sternotomies
  • Conditions making them not candidates for vicryl skin closure
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
36 participants (actual)

Study arms

  • Active comparator
    1 Vicryl Suture

    Patients will have their incision closed with vicryl suture

    Procedure: Vicryl Suture

  • Experimental
    2 Steri-Strips

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

    Device: 3M TM S Surgical Skin Closure System

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

06

What researchers measure

Primary outcomes

  1. Incidence of erythema

    Time frame: 30 days following surgery

Secondary outcomes

  1. Incidence of infection

    Time frame: 30 days following surgery

07

Study locations

1 site
  • Boston Medical Center
    Boston, Massachusetts 02118, United States
08

References and documents

Publications

  • 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. PubMed 21554389 ↗
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Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Sep 2007, a primary completion of Nov 2010 and a completion of Dec 2010. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 18, 2007
First posted
Dec 19, 2007
Start
Sep 2007
Primary completionActual
Nov 2010
CompletionActual
Dec 2010
Last update
Jul 18, 2012
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 18, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00576745
Lead sponsor
American Heart Association
Responsible party
Harold L. Lazar MD (Professor of Cardiothoracic Surgery, Boston Medical Center) — Principal investigator
First posted
Dec 19, 2007
Start date
Sep 2007
Primary completion
Nov 2010
Completion
Dec 2010
Last update
Jul 18, 2012

Study contacts

Harold L Lazar MD
principal investigator · Boston Medical Center

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2012. You cannot join it, but the record below documents what was studied.

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