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.

Study Overview

• Status: Completed
• Conditions: Impaired Wound Healing; Postoperative Wound Infection-deep
• Intervention / Treatment: Other: Dry Sterile Dressing; Other: Metallic Silver Dressing; Other: Ionic Silver Dressing

Detailed Description

No other information included.

• Study Type: Interventional
• Enrollment (Actual): 351
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Roanoke, Virginia, United States, 24014
      • Carilion Roanoke Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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 Names: 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 Names: 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 Names: Dermanet (DeRoyal)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Wound Healing	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.	5 days postoperatively or day of discharge, whichever came first

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Comfort	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.	5 days postoperatively or day of hospital discharge, whichever came first

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Dressing Factors	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.	5 days postoperatively or at day of discharge, whichever came first
Sternal Wound Infection	Investigators evaluated sternal wound infection presence and type (superficial or deep) using Centers for Disease Control/National Healthcare Safety Network surveillance definitions.	30 days postoperatively

Collaborators and Investigators

• Sponsor: Carilion Clinic
• Collaborators: Smith & Nephew, Inc.; DeRoyal Industries, Inc.
• Investigators: Principal Investigator: Cathy D. Jennings, DNP, Carilion Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2010
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: July 21, 2014
• First Posted (Estimate): July 23, 2014

Study Record Updates

• Last Update Posted (Estimate): July 23, 2014
• Last Update Submitted That Met QC Criteria: July 21, 2014
• Last Verified: March 1, 2014

More Information

Terms related to this study

• Keywords: Sternotomy incision; Silver dressing; Sternal wound infection
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Postoperative Complications; Wounds and Injuries; Surgical Wound Infection; Wound Infection
• Other Study ID Numbers: CC-2014-1