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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

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Impaired Wound Healing Postoperative Wound Infection-deep Other: Dry Sterile Dressing Other: Metallic Silver Dressing Other: Ionic Silver Dressing Not Applicable

Detailed Description:
No other information included.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 351 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Comparison of Post-Sternotomy Dressings
Study Start Date : July 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
Other: Dry Sterile Dressing
Described in Arm Description.
Other Name: Primapore (Smith & Nephew)

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.
Other: Metallic Silver Dressing
Described in Arm Description.
Other Name: Acticoat Post-Op (Smith & Nephew)

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).
Other: Ionic Silver Dressing
Described in Arm Description.
Other Name: Dermanet (DeRoyal)




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02198066


Locations
United States, Virginia
Carilion Roanoke Memorial Hospital
Roanoke, Virginia, United States, 24014
Sponsors and Collaborators
Carilion Clinic
DeRoyal Industries, Inc.
Smith & Nephew, Inc.
Investigators
Principal Investigator: Cathy D. Jennings, DNP Carilion Clinic

Responsible Party: Carilion Clinic
ClinicalTrials.gov Identifier: NCT02198066     History of Changes
Other Study ID Numbers: CC-2014-1
First Posted: July 23, 2014    Key Record Dates
Last Update Posted: July 23, 2014
Last Verified: March 2014

Keywords provided by Carilion Clinic:
Sternotomy incision
Silver dressing
Sternal wound infection

Additional relevant MeSH terms:
Wounds and Injuries
Wound Infection
Surgical Wound Infection
Infection
Postoperative Complications
Pathologic Processes