A Comparison of Post-Sternotomy Dressings

NCT ID: NCT02198066

Last Updated: 2014-07-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

351 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2012-08-31

Brief Summary

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The purpose of this study was to determine which of three types of dressings, a dry sterile dressing, a metallic silver dressing or an ionic silver dressing provided better patient outcomes for the post-sternotomy cardiac surgery patient population. In this prospective, randomized controlled trial, the hypothesis was that subjects who received either of the silver impregnated dressings would have better outcomes (better wound healing, less discomfort, and less incidence of infection). Investigators also evaluated dressing factors such as adherence, time for application and ease of use.

Detailed Description

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No other information included.

Conditions

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Impaired Wound Healing Postoperative Wound Infection-deep

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Dry Sterile Dressing

Subjects in this study arm received a dry sterile dressing (Primapore®, Smith \& Nephew), a one-piece, peel-and-stick, non-transparent dressing. This dressing is the standard of care at the study facility for this population and was left in place for either 24 to 48 hours.

Group Type OTHER

Dry Sterile Dressing

Intervention Type OTHER

Described in Arm Description.

Metallic Silver Dressing

Subjects in this arm received a metallic silver dressing (Acticoat Post-Op®, Smith \& Nephew), a one-piece, peel-and-stick and non-transparent dressing. This dressing is an absorbent postoperative dressing consisting of a nanocrystalline silver-coated polyurethane layer, a white polyurethane foam and an adhesive coated waterproof polyurethane film layer. Acticoat Post-Op may be left in place over a wound for up to 7 days. The manufacturers note that the product should not be used in patients with known silver allergies and that it may cause transient discoloration of the skin.

Group Type ACTIVE_COMPARATOR

Metallic Silver Dressing

Intervention Type OTHER

Described in Arm Description.

Ionic Silver Dressing

Subjects in this arm received an ionic silver dressing (Dermanet Ag®, DeRoyal), a semi-transparent dressing that includes silver, alginate, and maltodextrin. The dressing was cut to fit the incision and then covered with a transparent dressing (Transseal®, DeRoyal). This dressing should not be used on patients with known sensitivity to alginates (a seaweed based component).

Group Type ACTIVE_COMPARATOR

Ionic Silver Dressing

Intervention Type OTHER

Described in Arm Description.

Interventions

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Dry Sterile Dressing

Described in Arm Description.

Intervention Type OTHER

Metallic Silver Dressing

Described in Arm Description.

Intervention Type OTHER

Ionic Silver Dressing

Described in Arm Description.

Intervention Type OTHER

Other Intervention Names

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Primapore (Smith & Nephew) Acticoat Post-Op (Smith & Nephew) Dermanet (DeRoyal)

Eligibility Criteria

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Inclusion Criteria

* Adult (at least 21 years of age) inpatients awaiting cardiac surgery or outpatients seen in the pre-surgical testing area prior to admission for surgery
* Having surgery at the study setting
* English-speaking
* Able to understand and give consent
* Had the approval of their cardiothoracic surgeon to participate
* Had no known sensitivity to silver
* Had no known sensitivity to alginates

Exclusion Criteria

* Known sensitivity to silver
* Known sensitivity to alginates
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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DeRoyal Industries, Inc.

INDUSTRY

Sponsor Role collaborator

Smith & Nephew, Inc.

INDUSTRY

Sponsor Role collaborator

Carilion Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Cathy D. Jennings, DNP

Role: PRINCIPAL_INVESTIGATOR

Carilion Clinic

Locations

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Carilion Roanoke Memorial Hospital

Roanoke, Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CC-2014-1

Identifier Type: -

Identifier Source: org_study_id

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