A Comparison of Post-Sternotomy Dressings

Carilion Clinic

Status: Completed

Conditions: Postoperative Wound Infection-deep; Impaired Wound Healing

Treatments: Other: Metallic Silver Dressing; Other: Ionic Silver Dressing; Other: Dry Sterile Dressing

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02198066

CC-2014-1

Details and patient eligibility

About

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.

Full description

No other information included.

Enrollment: 351 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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351 participants in 3 patient groups

Dry Sterile Dressing

Other group

Description:

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.

Treatment:

Other: Dry Sterile Dressing

Metallic Silver Dressing

Active Comparator group

Description:

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.

Treatment:

Other: Metallic Silver Dressing

Ionic Silver Dressing

Active Comparator group

Description:

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).

Treatment:

Other: Ionic Silver Dressing