Impaired Wound Healing, Postoperative Wound Infection-deep
Conditions
Keywords
Sternotomy incision, Silver dressing, Sternal wound infection
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.
Detailed description
No other information included.
Interventions
OTHERDry Sterile Dressing
Described in Arm Description.
OTHERMetallic Silver Dressing
Described in Arm Description.
OTHERIonic Silver Dressing
Described in Arm Description.
Sponsors
DeRoyal Industries, Inc.
Smith & Nephew, Inc.
Carilion Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Wound Healing | 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
| Measure | Time frame | Description |
|---|---|---|
| Patient Comfort | 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
| Measure | Time frame | Description |
|---|---|---|
| Dressing Factors | 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. |
| Sternal Wound Infection | 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. |
Countries
United States
Outcome results
None listed