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Completed

NCT Number: NCT02198066

A Comparison of Post-Sternotomy Dressings

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

About this study

No other information included.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dry Sterile Dressing

Other

Described in Arm Description.

Other names: Primapore (Smith & Nephew)

Metallic Silver Dressing

Other

Described in Arm Description.

Other names: Acticoat Post-Op (Smith & Nephew)

Ionic Silver Dressing

Other

Described in Arm Description.

Other names: Dermanet (DeRoyal)

Primary outcomes

  1. Wound Healing

    Time frame: 5 days postoperatively or day of discharge, whichever came first

    The primary outcome measure in this study was wound healing, defined as the degree of wound approximation, skin integrity, exudate, and presence/absence of necrotic tissue, assessed at postoperative day 5 or day of discharge. Wound approximation was assessed as total, partial (less than 2 centimeters of superficial separation), moderate (greater than 2 centimeters of superficial separation), or dehisced (complete separation of layers). Skin integrity was evaluated as normal (pink, no redness), inflamed, (heat, redness, swelling), or macerated within a 2.5 centimeter border of the incision. Exudate quality was assessed as purulent, blood, serosanguinous, or serous. Presence or absence of necrotic tissue was noted.

Secondary outcomes

  1. Patient Comfort

    Time frame: 5 days postoperatively or day of hospital discharge, whichever came first

    The secondary outcome measure in this study was patient comfort with the dressing in place and upon removal. Comfort was measured using a 0-10 scale, with 0 signifying no pain and 10 signifying maximum pain.

Other outcomes

  1. Dressing Factors

    Time frame: 5 days postoperatively or at day of discharge, whichever came first

    Dressing factors of ease of application, removal, and incision assessment were measured on a 5-point Likert-type scale (1=very easy, 2=moderately easy, 3=neither easy nor hard, 4=moderately hard, and 5=very hard). Dressing integrity was assessed as suture line exposed, poorly sealed (imperfect covering of the suture line with the potential for organism entry), or well-sealed.

  2. Sternal Wound Infection

    Time frame: 30 days postoperatively

    Investigators evaluated sternal wound infection presence and type (superficial or deep) using Centers for Disease Control/National Healthcare Safety Network surveillance definitions.

Sponsors and collaborators

Lead sponsor

Carilion Clinic

Other

Collaborators

  • DeRoyal Industries, Inc.
  • Smith & Nephew, Inc.

Registry information

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jul 23, 2014
Registry last updated
Jul 23, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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