NCT00576745

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2007

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 18, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 19, 2007

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

July 18, 2012

Status Verified

July 1, 2012

Enrollment Period

3.2 years

First QC Date

December 18, 2007

Last Update Submit

July 17, 2012

Conditions

Wound Infection

Keywords

Sutures

Outcome Measures

Primary Outcomes (1)

  • Incidence of erythema

    30 days following surgery

Secondary Outcomes (1)

  • Incidence of infection

    30 days following surgery

Study Arms (2)

1 Vicryl Suture

ACTIVE COMPARATOR

Patients will have their incision closed with vicryl suture

Procedure: Vicryl Suture

2 Steri-Strips

EXPERIMENTAL

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

Device: 3M TM S Surgical Skin Closure System

Interventions

Vicryl SuturePROCEDURE

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

1 Vicryl Suture
3M TM S Surgical Skin Closure SystemDEVICE

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

2 Steri-Strips

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing mediastinotomy for cardiac surgical procedures

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston Medical Center

Boston, Massachusetts, 02118, United States

Location

Related Publications (1)

  • 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.

    PMID: 21554389RESULT

MeSH Terms

Conditions

Wound Infection

Condition Hierarchy (Ancestors)

Infections

Study Officials

  • Harold L Lazar MD

    Boston Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Cardiothoracic Surgery

Study Record Dates

First Submitted

December 18, 2007

First Posted

December 19, 2007

Study Start

September 1, 2007

Primary Completion

November 1, 2010

Study Completion

December 1, 2010

Last Updated

July 18, 2012

Record last verified: 2012-07

Locations

US(1)