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| Name | Class |
|---|---|
| DeRoyal Industries, Inc. | INDUSTRY |
| Smith & Nephew, Inc. | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry Sterile Dressing | Other | Described in Arm Description. |
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| 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 |
| 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 |
| 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 |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cathy D. Jennings, DNP | Carilion Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carilion Roanoke Memorial Hospital | Roanoke | Virginia | 24014 | United States |
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| Metallic Silver Dressing | Other | Described in Arm Description. |
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| Ionic Silver Dressing | Other | Described in Arm Description. |
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| 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 |