Effects of a New Antimicrobial Dressing on Wound Healing... | NCT00203541

Studies
Effects of a New Antimicrobial Dressing on Wound Healing and Incidence of Sternal Wound Infections

NCT00203541

Sponsor

Tyco Healthcare Group

Status

Terminated

Last Update Posted

Nov 19, 2007Estimated

Enrollment

1,100

Phase

Not Applicable

Conditions

Surgical Wound Infection

Interventions

TELFA™ A.M.D. Island dressing

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2007

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Reallocation of funding.

Expanded Access Info

Start Date

Feb 2004

Primary Completion Date

Not provided

Completion Date

Jun 2006

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 14, 2005

First Posted Date

Sep 20, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 16, 2007

Last Update Posted Date

Nov 19, 2007Estimated

Description Module

Brief Summary

The primary objective of this pivotal study is to determine if a new antimicrobial dressing, applied to the sternal incisions of cardiac surgical subjects, will demonstrate a decreased cumulative incidence rate(CI) of localized, superficial infections at the sternal incisional site as compared to the control group, regular, non-antimicrobial dressing.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

1,100

Name	Type	Description	Arm Group Labels	Other Names
TELFA™ A.M.D. Island dressing	Device

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Decreased cumulative incidence rate of superficial surgical site infections localized at the sternal incision in the treatment group as compared to the control group.

Secondary Outcomes

Measure	Description	Time Frame
Reduction of microbial log counts at the incisional site in the treatment group compared to the control group; Decreased cumulative incidence of mediastinitis in the treatment group as compared to the control group

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Sign an informed consent form that has been approved by the Institutional Review Board.
Adults at least 18 years of age.
Be undergoing cardiopulmonary bypass surgery with a median sternotomy.
Be able to return to the study site, if needed, to have the sternal surgical incision site inspected.

Exclusion Criteria:

Be participating concurrently in another clinical trial that involves an investigational drug or device that would interfere with this study.
Be in need of a left ventricular assist device.
Have an active pre-operative infectious process.
Subject is to receive another topical antimicrobial agent (i.e., Dermabond® Topical Skin Adhesive) other than the study dressing (as assigned by the randomization schedule).

Accepts Healthy Volunteers

Not provided

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Katie Kavounis, MPH	Tyco Healthcare/Kendall	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Duke University		Durham	North Carolina	27705	United States

Condition Browse Module

MeSH Terms

ID	Term
D013530	Surgical Wound Infection

Ancestor Terms

ID	Term
D014946	Wound Infection
D007239	Infections
D011183	Postoperative Complications
D010335	Pathologic Processes

Browse Leaves

Not provided

Browse Branches

Not provided