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A Comparison of Post-Sternotomy Dressings

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ClinicalTrials.gov Identifier: NCT02198066
Recruitment Status : Completed
First Posted : July 23, 2014
Last Update Posted : July 23, 2014
Sponsor:
Collaborators:
DeRoyal Industries, Inc.
Smith & Nephew, Inc.
Information provided by (Responsible Party):
Carilion Clinic

March 27, 2014
July 23, 2014
July 23, 2014
July 2010
August 2012   (Final data collection date for primary outcome measure)
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.
Same as current
No Changes Posted
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.
Same as current
  • 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.
  • 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.
Same as current
 
A Comparison of Post-Sternotomy Dressings
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.
No other information included.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
  • Impaired Wound Healing
  • Postoperative Wound Infection-deep
  • Other: Dry Sterile Dressing
    Described in Arm Description.
    Other Name: Primapore (Smith & Nephew)
  • Other: Metallic Silver Dressing
    Described in Arm Description.
    Other Name: Acticoat Post-Op (Smith & Nephew)
  • Other: Ionic Silver Dressing
    Described in Arm Description.
    Other Name: Dermanet (DeRoyal)
  • 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.
    Intervention: Other: Dry Sterile Dressing
  • Active Comparator: 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.
    Intervention: Other: Metallic Silver Dressing
  • Active Comparator: 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).
    Intervention: Other: Ionic Silver Dressing
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
351
Same as current
August 2012
August 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT02198066
CC-2014-1
No
Not Provided
Not Provided
Carilion Clinic
Carilion Clinic
  • DeRoyal Industries, Inc.
  • Smith & Nephew, Inc.
Principal Investigator: Cathy D. Jennings, DNP Carilion Clinic
Carilion Clinic
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP