A Comparison of Post-Sternotomy Dressings

NCT02198066 | Completed

• 1 other identifier: CC-2014-1
• Study Type: interventional
• Target: 351
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Wound Healing; Postoperative Wound Infection-deep

Keywords

Sternotomy incision; Silver dressing; Sternal wound infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient Comfort

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

Other Outcomes (2)

• Dressing Factors

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

• Sternal Wound Infection

  30 days postoperatively

Study Arms (3)

Dry Sterile Dressing

OTHER

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

Metallic Silver Dressing

ACTIVE COMPARATOR

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

Ionic Silver Dressing

ACTIVE COMPARATOR

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

Interventions

Dry Sterile Dressing OTHER

Described in Arm Description.

Also known as: Primapore (Smith & Nephew)

Dry Sterile Dressing

Metallic Silver Dressing OTHER

Described in Arm Description.

Also known as: Acticoat Post-Op (Smith & Nephew)

Metallic Silver Dressing

Ionic Silver Dressing OTHER

Described in Arm Description.

Also known as: Dermanet (DeRoyal)

Ionic Silver Dressing

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Known sensitivity to silver
• Known sensitivity to alginates

Sponsors & Collaborators

• Carilion Clinic: lead
• DeRoyal Industries, Inc.: collaborator
• Smith & Nephew, Inc.: collaborator

Study Sites (1)

Carilion Roanoke Memorial Hospital

Roanoke, Virginia, 24014, United States

Location

Study Officials

• Cathy D. Jennings, DNP

  Carilion Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: July 23, 2014
• Study Start: July 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 23, 2014

Record last verified: 2014-03

Locations

US (1)